Trial Outcomes & Findings for 3,3'-Dioxo-2,2'-Bisindolylidene-5,5'-Disulfonate Disodium 0.8% Solution as an Aid for Ureteral Patency (NCT NCT04228445)

Last Updated: 2022-11-30

Results Overview

The urine jet conspicuity score provided by the blinded central review process as assessed by the following 5-point ordinal scale. 1. = No jet observed 2. = Weak jet, little color contrast 3. = Color contrast or significant jet flow 4. = Strong jet flow with good color contrast 5. = Strong jet flow with striking contrast in color

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

121 participants

Primary outcome timeframe

10 minutes

Results posted on

2022-11-30

Participant Flow

This was a crossover study where each subject served as their own control, so each subject received the control (saline solution) was evaluated for the endpoints and then received either the high or low dose based on their randomization assignment. So the total number of participants were 121 although each participant provided data for one of the active groups and the saline group.

Participant milestones

Participant milestones
Measure	SALINE Then HIGH DOSE Approximately 48 subjects treated with 5 ml of saline than crossover to be treated with 5 mL of drug 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%: Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice. Saline solution: Placebo	SALINE Then LOW DOSE Approximately 48 subjects treated with 5 ml of saline than crossover to be treated with 2.5 mL of drug 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%: Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice. Saline solution: Placebo
Overall Study STARTED	62	59
Overall Study COMPLETED	59	55
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	SALINE Then HIGH DOSE Approximately 48 subjects treated with 5 ml of saline than crossover to be treated with 5 mL of drug 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%: Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice. Saline solution: Placebo	SALINE Then LOW DOSE Approximately 48 subjects treated with 5 ml of saline than crossover to be treated with 2.5 mL of drug 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%: Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice. Saline solution: Placebo
Overall Study Lost to Follow-up	1	1
Overall Study Physician Decision	1	2
Overall Study Withdrawal by Subject	0	1
Overall Study Planned procedure not performed after randomization, study drug not administered	1	0

Baseline Characteristics

3,3'-Dioxo-2,2'-Bisindolylidene-5,5'-Disulfonate Disodium 0.8% Solution as an Aid for Ureteral Patency

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SALINE Then HIGH DOSE n=60 Participants Approximately 48 subjects treated with 5 ml of saline than crossover to be treated with 5 mL of drug 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%: Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice. Saline solution: Placebo	SALINE Then LOW DOSE n=58 Participants Approximately 48 subjects treated with 5 ml of saline than crossover to be treated with 2.5 mL of drug 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%: Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice. Saline solution: Placebo	Total n=118 Participants Total of all reporting groups
Age, Customized < 65 years old	42 Participants n=39 Participants	41 Participants n=41 Participants	83 Participants n=35 Participants
Age, Customized >/= 65 years to <75 years old	11 Participants n=39 Participants	12 Participants n=41 Participants	23 Participants n=35 Participants
Age, Customized >/= 75 years old	7 Participants n=39 Participants	5 Participants n=41 Participants	12 Participants n=35 Participants
Sex: Female, Male Female	42 Participants n=39 Participants	45 Participants n=41 Participants	87 Participants n=35 Participants
Sex: Female, Male Male	18 Participants n=39 Participants	13 Participants n=41 Participants	31 Participants n=35 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=39 Participants	8 Participants n=41 Participants	18 Participants n=35 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	50 Participants n=39 Participants	48 Participants n=41 Participants	98 Participants n=35 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants	2 Participants n=41 Participants	2 Participants n=35 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Asian	0 Participants n=39 Participants	2 Participants n=41 Participants	2 Participants n=35 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Black or African American	4 Participants n=39 Participants	4 Participants n=41 Participants	8 Participants n=35 Participants
Race (NIH/OMB) White	56 Participants n=39 Participants	49 Participants n=41 Participants	105 Participants n=35 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants	3 Participants n=41 Participants	3 Participants n=35 Participants
Region of Enrollment United States	60 participants n=39 Participants	58 participants n=41 Participants	118 participants n=35 Participants

PRIMARY outcome

Timeframe: 10 minutes

Population: The efficacy analysis set, also referred to as the modified intent-to-treat (mITT) analysis set, included all subjects in the safety analysis set who had a surgical procedure to assess ureteral patency, who received both study drugs (saline and indigo carmine), and a video approximately 10 minutes in length was available after each treatment.

Outcome measures

Outcome measures
Measure	HIGH DOSE n=49 Participants Approximately 48 subjects randomly treated with 5 mL of drug 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%: Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice. Saline solution: Placebo	LOW DOSE n=47 Participants Approximately 48 subjects randomly treated with 2.5 mL of drug 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%: Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice. Saline solution: Placebo	Saline n=96 Participants Approximately 96 subjects treated with 5 ml of saline than crossover to treatment arm Saline solution: Placebo
Urine Jet Conspicuity Score	4.1 score on a scale Standard Deviation 1.34	4.2 score on a scale Standard Deviation 1.17	2.5 score on a scale Standard Deviation 1.10

SECONDARY outcome

Timeframe: 10 Minutes

A subject was a responder when there was ≥1-point improvement in the urine jet conspicuity scores following the indigo carmine versus saline treatment (indigo carmine - saline ≥1) and the conspicuity score following the indigo carmine treatment was 3, 4, or 5. The responder criteria were assessed separately for each ureter for each subject based on the blinded central reviewer's conspicuity score.

Outcome measures

Outcome measures
Measure	HIGH DOSE n=49 Participants Approximately 48 subjects randomly treated with 5 mL of drug 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%: Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice. Saline solution: Placebo	LOW DOSE n=47 Participants Approximately 48 subjects randomly treated with 2.5 mL of drug 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%: Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice. Saline solution: Placebo	Saline Approximately 96 subjects treated with 5 ml of saline than crossover to treatment arm Saline solution: Placebo
Percentage of Responders Responder	43 Participants	41 Participants	—
Percentage of Responders Non-Responder	6 Participants	6 Participants	—

SECONDARY outcome

Timeframe: 10 Minutes

After the completion of the procedure, the surgeon rated the experience of using indigo carmine for each subject using the 5-point PSAS, in which: "Compared to the use of saline treatment, my ability to assess ureteral patency was improved after the addition of indigo carmine." 1. = Strongly Agree 2. = Agree 3. = Neither Agree nor Disagree 4. = Disagree 5. = Strongly Disagree The surgeon was considered satisfied with the indigo carmine treatment if his/her rating was either a 1 (strongly agree) or a 2 (agree); otherwise, the surgeon was considered unsatisfied with the indigo carmine treatment.

Outcome measures

Outcome measures
Measure	HIGH DOSE n=49 Participants Approximately 48 subjects randomly treated with 5 mL of drug 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%: Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice. Saline solution: Placebo	LOW DOSE n=47 Participants Approximately 48 subjects randomly treated with 2.5 mL of drug 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%: Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice. Saline solution: Placebo	Saline Approximately 96 subjects treated with 5 ml of saline than crossover to treatment arm Saline solution: Placebo
Physician Satisfaction Agreement Scale Satisfied (score of 1 or 2)	44 Participants	38 Participants	—
Physician Satisfaction Agreement Scale Unsatisfied (Score of 3,4 or 5)	5 Participants	9 Participants	—

SECONDARY outcome

Timeframe: 10 Minutes

Time to visualization (minutes) of blue color in the ureteral jets flow following indigo carmine treatment

Outcome measures

Outcome measures
Measure	HIGH DOSE n=49 Participants Approximately 48 subjects randomly treated with 5 mL of drug 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%: Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice. Saline solution: Placebo	LOW DOSE n=47 Participants Approximately 48 subjects randomly treated with 2.5 mL of drug 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%: Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice. Saline solution: Placebo	Saline Approximately 96 subjects treated with 5 ml of saline than crossover to treatment arm Saline solution: Placebo
Time to Visualization	6.00 Minutes Interval 5.25 to 7.0	5.93 Minutes Interval 5.12 to 7.0	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 10 Minutes

The urine jet conspicuity score provided by the surgeon as assessed by the following 5-point ordinal scale. 1. = No jet observed 2. = Weak jet, little color contrast 3. = Color contrast or significant jet flow 4. = Strong jet flow with good color contrast 5. = Strong jet flow with striking contrast in color

Outcome measures

Outcome measures
Measure	HIGH DOSE n=47 Participants Approximately 48 subjects randomly treated with 5 mL of drug 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%: Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice. Saline solution: Placebo	LOW DOSE n=46 Participants Approximately 48 subjects randomly treated with 2.5 mL of drug 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%: Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice. Saline solution: Placebo	Saline n=93 Participants Approximately 96 subjects treated with 5 ml of saline than crossover to treatment arm Saline solution: Placebo
Surgeon Urine Jet Conspicuity Score	4.2 score on a scale Standard Deviation 1.31	4.2 score on a scale Standard Deviation 1.26	2.4 score on a scale Standard Deviation 1.07

OTHER_PRE_SPECIFIED outcome

Timeframe: 10 Min

Population: mITT Analysis Set; Subjects Without Missing Surgeon or Central Assessment Data

Concordance of conspicuity scores between the surgeons' assessments and the blinded central reviewer assessments. If the difference between raters in conspicuity score was within ±1 (ie, the difference ranged from 1 to +1, inclusive), the scores were considered to agree. The urine jet conspicuity score as assessed by the following 5-point ordinal scale. 1. = No jet observed 2. = Weak jet, little color contrast 3. = Color contrast or significant jet flow 4. = Strong jet flow with good color contrast 5. = Strong jet flow with striking contrast in color

Outcome measures

Outcome measures
Measure	HIGH DOSE n=45 Participants Approximately 48 subjects randomly treated with 5 mL of drug 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%: Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice. Saline solution: Placebo	LOW DOSE n=43 Participants Approximately 48 subjects randomly treated with 2.5 mL of drug 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%: Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice. Saline solution: Placebo	Saline n=88 Participants Approximately 96 subjects treated with 5 ml of saline than crossover to treatment arm Saline solution: Placebo
Concordance of Conspicuity Scores Left Ureter · Agreement	41 Participants	38 Participants	67 Participants
Concordance of Conspicuity Scores Left Ureter · Disagreement	4 Participants	5 Participants	21 Participants
Concordance of Conspicuity Scores Right ureter · Agreement	43 Participants	37 Participants	63 Participants
Concordance of Conspicuity Scores Right ureter · Disagreement	2 Participants	6 Participants	25 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 10 minutes

Population: mITT Analysis Set

Exploratory analysis of the urine jet conspicuity score difference between the indigo carmine high dose and indigo carmine low dose by central review Process The urine jet conspicuity score provided by the blinded central review process as assessed by the following 5-point ordinal scale. 1. = No jet observed 2. = Weak jet, little color contrast 3. = Color contrast or significant jet flow 4. = Strong jet flow with good color contrast 5. = Strong jet flow with striking contrast in color

Outcome measures

Outcome measures
Measure	HIGH DOSE n=49 Participants Approximately 48 subjects randomly treated with 5 mL of drug 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%: Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice. Saline solution: Placebo	LOW DOSE n=47 Participants Approximately 48 subjects randomly treated with 2.5 mL of drug 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%: Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice. Saline solution: Placebo	Saline Approximately 96 subjects treated with 5 ml of saline than crossover to treatment arm Saline solution: Placebo
Conspicuity Score Difference Between the Indigo Carmine High Dose and Indigo Carmine Low Dose by Central Review Process	4.1 score on a scale Standard Deviation 1.34	4.2 score on a scale Standard Deviation 1.17	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 10 Minutes

Population: mITT population

Exploratory analysis of conspicuity score difference between the indigo carmine high dose and indigo carmine low dose as assessed by surgeons who were blinded to the dose of indigo carmine The urine jet conspicuity score as assessed by the following 5-point ordinal scale. 1. = No jet observed 2. = Weak jet, little color contrast 3. = Color contrast or significant jet flow 4. = Strong jet flow with good color contrast 5. = Strong jet flow with striking contrast in color

Outcome measures

Outcome measures
Measure	HIGH DOSE n=47 Participants Approximately 48 subjects randomly treated with 5 mL of drug 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%: Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice. Saline solution: Placebo	LOW DOSE n=46 Participants Approximately 48 subjects randomly treated with 2.5 mL of drug 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%: Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice. Saline solution: Placebo	Saline Approximately 96 subjects treated with 5 ml of saline than crossover to treatment arm Saline solution: Placebo
Conspicuity Score Difference Between the Indigo Carmine High Dose and Indigo Carmine Low Dose as Assessed by Surgeons Who Were Blinded to the Dose of Indigo Carmine	4.2 score on a scale Standard Deviation 1.31	4.2 score on a scale Standard Deviation 1.26	—

Adverse Events

HIGH DOSE

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

LOW DOSE

Serious events: 3 serious events

Other events: 14 other events

Deaths: 0 deaths

Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	HIGH DOSE n=60 participants at risk Approximately 48 subjects randomly treated with 5 mL of drug 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%: Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice. Saline solution: Placebo	LOW DOSE n=58 participants at risk Approximately 48 subjects randomly treated with 2.5 mL of drug 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%: Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice. Saline solution: Placebo	Saline n=118 participants at risk Approximately 96 subjects treated with 5 ml of saline than crossover to treatment arm Saline solution: Placebo
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration (Aspiration pneumonia)	0.00% 0/60 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.	1.7% 1/58 • Number of events 1 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.	0.00% 0/118 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism (Bilateral PE)	0.00% 0/60 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.	1.7% 1/58 • Number of events 1 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.	0.00% 0/118 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.
Vascular disorders Deep vein thrombosis (Left iliac DVT)	0.00% 0/60 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.	1.7% 1/58 • Number of events 1 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.	0.00% 0/118 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.
Cardiac disorders Atrioventricular block complete	0.00% 0/60 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.	1.7% 1/58 • Number of events 1 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.	0.00% 0/118 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.
Infections and infestations Pyelonephritis	1.7% 1/60 • Number of events 1 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.	0.00% 0/58 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.	0.00% 0/118 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.
Gastrointestinal disorders Nausea	1.7% 1/60 • Number of events 1 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.	0.00% 0/58 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.	0.00% 0/118 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.
Gastrointestinal disorders Vomiting	1.7% 1/60 • Number of events 1 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.	0.00% 0/58 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.	0.00% 0/118 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.

Other adverse events

Other adverse events
Measure	HIGH DOSE n=60 participants at risk Approximately 48 subjects randomly treated with 5 mL of drug 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%: Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice. Saline solution: Placebo	LOW DOSE n=58 participants at risk Approximately 48 subjects randomly treated with 2.5 mL of drug 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%: Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice. Saline solution: Placebo	Saline n=118 participants at risk Approximately 96 subjects treated with 5 ml of saline than crossover to treatment arm Saline solution: Placebo
Gastrointestinal disorders Constipation	5.0% 3/60 • Number of events 3 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.	5.2% 3/58 • Number of events 3 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.	0.00% 0/118 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.
Gastrointestinal disorders Abdominal pain	3.3% 2/60 • Number of events 2 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.	1.7% 1/58 • Number of events 1 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.	0.00% 0/118 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.
Gastrointestinal disorders Nausea	3.3% 2/60 • Number of events 2 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.	1.7% 1/58 • Number of events 1 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.	0.00% 0/118 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.
Gastrointestinal disorders Vomiting	3.3% 2/60 • Number of events 2 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.	0.00% 0/58 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.	0.00% 0/118 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.
Gastrointestinal disorders Dyspepsia	0.00% 0/60 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.	3.4% 2/58 • Number of events 2 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.	0.00% 0/118 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.
Renal and urinary disorders Dysuria	1.7% 1/60 • Number of events 1 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.	6.9% 4/58 • Number of events 4 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.	0.00% 0/118 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.
Investigations Alanine aminotransferase increased	3.3% 2/60 • Number of events 2 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.	0.00% 0/58 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.	0.00% 0/118 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.
General disorders Pyrexia	3.3% 2/60 • Number of events 2 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.	1.7% 1/58 • Number of events 1 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.	0.00% 0/118 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/60 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.	3.4% 2/58 • Number of events 2 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.	0.00% 0/118 • Saline group: AEs collected from the time of saline administration until the beginning of indigo carmine administration (approximately 10 minutes) IC groups AEs collected from the start of IC administration until 30 (+/- 2) days post surgery AEs were collected through non leading questioning of participants as well as via scheduled post treatment evaluation of clinical laboratories, physical exam, vital signs and EKGs.

Additional Information

Senior Director of Clinical Operations

Provepharm, Inc.

Phone: 6106018605

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60