Trial Outcomes & Findings for Comparison of Fluid Capture Efficiency of the Total Capture Drape Versus a Standard Drape for Hysteroscopy (NCT NCT04540952)
NCT ID: NCT04540952
Last Updated: 2022-04-21
Results Overview
Surgery duration, and average of 30 minutes was used to measure hysteroscopic fluid deficit measured by the fulid management system by subtracting the outflow volume returned to the fluid management system from the inflow volume.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
68 participants
Primary outcome timeframe
Surgery Duration
Results posted on
2022-04-21
Participant Flow
Participant milestones
| Measure |
Total Capture Drape
Surgical drape created by Principal Investigator to adequately collect fluid during hysteroscopy procedure
Total Capture Drape: Surgical drape created by Principal Investigator to adequately collect fluid during hysteroscopy procedure
|
Control
Standard surgical drape used to adequately collect fluid during hysteroscopy procedure
Standard Hysteroscopy Drape: Standard surgical drape used to adequately collect fluid during hysteroscopy procedure
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
34
|
|
Overall Study
COMPLETED
|
34
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Fluid Capture Efficiency of the Total Capture Drape Versus a Standard Drape for Hysteroscopy
Baseline characteristics by cohort
| Measure |
Total Capture Drape
n=34 Participants
Surgical drape created by Principal Investigator to adequately collect fluid during hysteroscopy procedure
Total Capture Drape: Surgical drape created by Principal Investigator to adequately collect fluid during hysteroscopy procedure.
|
Control
n=34 Participants
Standard surgical drape used to adequately collect fluid during hysteroscopy procedure
Standard Hysteroscopy Drape: Standard surgical drape used to adequately collect fluid during hysteroscopy procedure.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Age, Continuous
|
42.4 years
STANDARD_DEVIATION 11.4 • n=99 Participants
|
41.0 years
STANDARD_DEVIATION 10.5 • n=107 Participants
|
41.7 years
STANDARD_DEVIATION 11.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=99 Participants
|
34 participants
n=107 Participants
|
68 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Surgery DurationSurgery duration, and average of 30 minutes was used to measure hysteroscopic fluid deficit measured by the fulid management system by subtracting the outflow volume returned to the fluid management system from the inflow volume.
Outcome measures
| Measure |
Control Group
n=33 Participants
Control group which used the standard surgical drape used to adequately collect fluid during hysteroscopy procedure
|
Total Capture Drape Group
n=34 Participants
TCD group which used the surgical drape created by Principal Investigator to adequately collect fluid during hysteroscopy procedure
|
|---|---|---|
|
Hysteroscopic Fluid Deficit (HFD) Measured by the Fluid Management System by Subtracting the Outflow Volume (OV) Returned to the Fluid Management System From the Inflow Volume (IV).
|
347.7 ml
Standard Deviation 474.1
|
359.1 ml
Standard Deviation 606.6
|
SECONDARY outcome
Timeframe: Surgery DurationUncollected fluid on operating room floor was documented as present or absent.
Outcome measures
| Measure |
Control Group
n=34 Participants
Control group which used the standard surgical drape used to adequately collect fluid during hysteroscopy procedure
|
Total Capture Drape Group
n=33 Participants
TCD group which used the surgical drape created by Principal Investigator to adequately collect fluid during hysteroscopy procedure
|
|---|---|---|
|
Number of Participants With Uncollected Distention Fluid Volume Found on Operating Room Floor and Bedding
|
14 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: 1 day (day of procedure)Observed if fluid management alarm indicated unsafe level of patient fluid absorption
Outcome measures
| Measure |
Control Group
n=34 Participants
Control group which used the standard surgical drape used to adequately collect fluid during hysteroscopy procedure
|
Total Capture Drape Group
n=33 Participants
TCD group which used the surgical drape created by Principal Investigator to adequately collect fluid during hysteroscopy procedure
|
|---|---|---|
|
Number of Participants With Hysteroscopy Fluid Management Alarm Activation
|
9 Participants
|
4 Participants
|
Adverse Events
Total Capture Drape
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place