Trial Outcomes & Findings for PillSense System for Detecting UGI Bleed (NCT NCT05385224)

Last Updated: 2023-10-26

Results Overview

To assess the sensitivity of the PillSense System in detecting the presence of blood in the stomach. The investigational device returns a result of either "Blood detected" or "No blood detected". Sensitivity = True Positives / (True Positives + False Negative). True positives were observations of bleed detected via PillSense capsule confirmed via esophagogastroduodenoscopy (EGD)\]. False negatives were observation of bleed not detected via capsule but EGD confirmed bleed.

Recruitment status

COMPLETED

Study phase

Target enrollment

131 participants

Primary outcome timeframe

Day 1

Results posted on

2023-10-26

Participant Flow

Subjects enrolled between December 10, 2021 and August 18, 2022 at the Mayo Clinic, Rochester, MN.

Participant milestones

Participant milestones
Measure	PillSense (Active) This is a single-arm, non-randomized study. PillSense: The PillSense System is intended to detect the presence of blood in the stomach for the evaluation of upper gastrointestinal bleeding.
Overall Study STARTED	131
Overall Study Modified Intent-to-Treat (Effectiveness Population)	124
Overall Study Safety Population	126
Overall Study COMPLETED	126
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	PillSense (Active) This is a single-arm, non-randomized study. PillSense: The PillSense System is intended to detect the presence of blood in the stomach for the evaluation of upper gastrointestinal bleeding.
Overall Study Unable to swallow capsule	2
Overall Study Withdrawal by Subject	2
Overall Study Did not meet study criteria	1

Baseline Characteristics

PillSense System for Detecting UGI Bleed

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PillSense (Active) n=126 Participants This is a single-arm, non-randomized study. PillSense: The PillSense System is intended to detect the presence of blood in the stomach for the evaluation of upper gastrointestinal bleeding.
Age, Continuous	62.4 years STANDARD_DEVIATION 14.3 • n=99 Participants
Sex: Female, Male Female	75 Participants n=99 Participants
Sex: Female, Male Male	51 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	122 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=99 Participants
Race (NIH/OMB) Asian	4 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants
Race (NIH/OMB) White	117 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants
Region of Enrollment United States	126 participants n=99 Participants

PRIMARY outcome

Timeframe: Day 1

Population: modified Intent to Treat

Outcome measures

Outcome measures
Measure	PillSense (Active) n=28 Participants This is a single-arm, non-randomized study. PillSense: The PillSense System is intended to detect the presence of blood in the stomach for the evaluation of upper gastrointestinal bleeding.
Sensitivity	26 Participants

PRIMARY outcome

Timeframe: Day 1

Population: modified Intent to Treat

To evaluate the specificity of the PillSense System in detecting the presence of blood in the stomach. The investigational device returns a result of either "Blood detected" or "No blood detected". Specificity=True Negatives / (True Negatives + False Positive). True negatives were observations of no bleed detected via PillSense capsule confirmed via esophagogastroduodenoscopy (EGD)\]. False positives were observation of bleed detected via capsule but EGD confirmed no bleed.

Outcome measures

Outcome measures
Measure	PillSense (Active) n=96 Participants This is a single-arm, non-randomized study. PillSense: The PillSense System is intended to detect the presence of blood in the stomach for the evaluation of upper gastrointestinal bleeding.
Specificity	87 Participants

SECONDARY outcome

Timeframe: Day 1

Population: True Negatives + False Negatives

Negative predictive value (NPV) for the PillSense System in detecting the presence of blood in the stomach. The investigational device returns a result of either "Blood detected" or "No blood detected".

Outcome measures

Outcome measures
Measure	PillSense (Active) n=89 Participants This is a single-arm, non-randomized study. PillSense: The PillSense System is intended to detect the presence of blood in the stomach for the evaluation of upper gastrointestinal bleeding.
NPV	87 Participants

SECONDARY outcome

Timeframe: Day 1 through Day 14

Population: Safety Population

To evaluate the transit of the PillSense Capsule through the GI tract. Passage of the capsule will be monitored until capsule has passed from the body. If subject or study team is unable to determine capsule passage visually, a confirmation x-ray or other imaging will be used to determine if the capsule is still present in the body.

Outcome measures

Outcome measures
Measure	PillSense (Active) n=126 Participants This is a single-arm, non-randomized study. PillSense: The PillSense System is intended to detect the presence of blood in the stomach for the evaluation of upper gastrointestinal bleeding.
Transit	3.6 days Standard Deviation 2.35

SECONDARY outcome

Timeframe: Day 1

Population: True Positives + False Positives

Positive predictive value (PPV) for the PillSense System in detecting the presence of blood in the stomach. The investigational device returns a result of either "Blood detected" or "No blood detected".

Outcome measures

Outcome measures
Measure	PillSense (Active) n=35 Participants This is a single-arm, non-randomized study. PillSense: The PillSense System is intended to detect the presence of blood in the stomach for the evaluation of upper gastrointestinal bleeding.
PPV	26 Participants

Adverse Events

PillSense (Active)

Serious events: 15 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PillSense (Active) n=126 participants at risk This is a single-arm, non-randomized study. PillSense: The PillSense System is intended to detect the presence of blood in the stomach for the evaluation of upper gastrointestinal bleeding.
Psychiatric disorders Suicidal Ideations	0.79% 1/126 • Number of events 1 • From Time of PillSense Administration through Follow-up Visit 3 (Up to 21 days). Treatment emergent adverse events defined as an adverse event that began or worsened during or after PillSense Capsule administration.
Social circumstances Alchohol withdrawal seizure	1.6% 2/126 • Number of events 2 • From Time of PillSense Administration through Follow-up Visit 3 (Up to 21 days). Treatment emergent adverse events defined as an adverse event that began or worsened during or after PillSense Capsule administration.
Gastrointestinal disorders Abdominal Distention / Abdominal Pain	2.4% 3/126 • Number of events 3 • From Time of PillSense Administration through Follow-up Visit 3 (Up to 21 days). Treatment emergent adverse events defined as an adverse event that began or worsened during or after PillSense Capsule administration.
Gastrointestinal disorders Bleeding	4.0% 5/126 • Number of events 5 • From Time of PillSense Administration through Follow-up Visit 3 (Up to 21 days). Treatment emergent adverse events defined as an adverse event that began or worsened during or after PillSense Capsule administration.
Nervous system disorders Altered Mental Status	0.79% 1/126 • Number of events 1 • From Time of PillSense Administration through Follow-up Visit 3 (Up to 21 days). Treatment emergent adverse events defined as an adverse event that began or worsened during or after PillSense Capsule administration.
Cardiac disorders Chest Pain with SOB	0.79% 1/126 • Number of events 1 • From Time of PillSense Administration through Follow-up Visit 3 (Up to 21 days). Treatment emergent adverse events defined as an adverse event that began or worsened during or after PillSense Capsule administration.
Vascular disorders Acute Limb Ischemia	0.79% 1/126 • Number of events 1 • From Time of PillSense Administration through Follow-up Visit 3 (Up to 21 days). Treatment emergent adverse events defined as an adverse event that began or worsened during or after PillSense Capsule administration.
Blood and lymphatic system disorders Amyloidosis and Multiple Myeloma	0.79% 1/126 • Number of events 1 • From Time of PillSense Administration through Follow-up Visit 3 (Up to 21 days). Treatment emergent adverse events defined as an adverse event that began or worsened during or after PillSense Capsule administration.
Hepatobiliary disorders Hemobilia	0.79% 1/126 • Number of events 1 • From Time of PillSense Administration through Follow-up Visit 3 (Up to 21 days). Treatment emergent adverse events defined as an adverse event that began or worsened during or after PillSense Capsule administration.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.79% 1/126 • Number of events 1 • From Time of PillSense Administration through Follow-up Visit 3 (Up to 21 days). Treatment emergent adverse events defined as an adverse event that began or worsened during or after PillSense Capsule administration.
Musculoskeletal and connective tissue disorders Back Pain	0.79% 1/126 • Number of events 1 • From Time of PillSense Administration through Follow-up Visit 3 (Up to 21 days). Treatment emergent adverse events defined as an adverse event that began or worsened during or after PillSense Capsule administration.
Surgical and medical procedures Failure to extubate	0.79% 1/126 • Number of events 1 • From Time of PillSense Administration through Follow-up Visit 3 (Up to 21 days). Treatment emergent adverse events defined as an adverse event that began or worsened during or after PillSense Capsule administration.

Other adverse events

Other adverse events
Measure	PillSense (Active) n=126 participants at risk This is a single-arm, non-randomized study. PillSense: The PillSense System is intended to detect the presence of blood in the stomach for the evaluation of upper gastrointestinal bleeding.
Gastrointestinal disorders Abdominal Pain	2.4% 3/126 • Number of events 3 • From Time of PillSense Administration through Follow-up Visit 3 (Up to 21 days). Treatment emergent adverse events defined as an adverse event that began or worsened during or after PillSense Capsule administration.
Infections and infestations Urinary Tract Infection	0.79% 1/126 • Number of events 1 • From Time of PillSense Administration through Follow-up Visit 3 (Up to 21 days). Treatment emergent adverse events defined as an adverse event that began or worsened during or after PillSense Capsule administration.
General disorders Lethargy	0.79% 1/126 • Number of events 1 • From Time of PillSense Administration through Follow-up Visit 3 (Up to 21 days). Treatment emergent adverse events defined as an adverse event that began or worsened during or after PillSense Capsule administration.
Musculoskeletal and connective tissue disorders Lumbar Fracture	0.79% 1/126 • Number of events 1 • From Time of PillSense Administration through Follow-up Visit 3 (Up to 21 days). Treatment emergent adverse events defined as an adverse event that began or worsened during or after PillSense Capsule administration.
Gastrointestinal disorders Diarrhea	0.79% 1/126 • Number of events 1 • From Time of PillSense Administration through Follow-up Visit 3 (Up to 21 days). Treatment emergent adverse events defined as an adverse event that began or worsened during or after PillSense Capsule administration.
Ear and labyrinth disorders Epistasix	0.79% 1/126 • Number of events 1 • From Time of PillSense Administration through Follow-up Visit 3 (Up to 21 days). Treatment emergent adverse events defined as an adverse event that began or worsened during or after PillSense Capsule administration.
Gastrointestinal disorders Duodenitis	0.79% 1/126 • Number of events 1 • From Time of PillSense Administration through Follow-up Visit 3 (Up to 21 days). Treatment emergent adverse events defined as an adverse event that began or worsened during or after PillSense Capsule administration.

Additional Information

David Collins, Director of Technical Operations

EnteraSense Ltd.

Phone: 091 750 246

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place