CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 131 enrolled
Drug / intervention
PillSenseother
Likely dose
Not stated in record
Key inclusion· 3
  • ✓Age 18 years or older
  • ✓Able to provide informed consent
  • ✓Clinical suspicion of UGIB
Key exclusion· 12
  • ✕Circulatory or hemodynamic instability
  • ✕Known GI tract stricture
  • ✕Using an implantable electrical device
  • ✕Difficulties swallowing pills the size of the capsule

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05385224
NCT05385224N/ACompleted
CompareCT.gov

A Clinical Study to Evaluate Effectiveness and Safety of the PillSense System in Detecting Blood in the Stomach for the Evaluation of Upper Gastrointestinal Bleeding (UGIB)

EnteraSense Limited·interventional·Posted May 23, 2022·Updated Oct 26, 2023

In Brief

A clinical study evaluating PillSense for UGI Bleed and 2 related conditions. Completed, enrolled 131 participants across 1 site.

Detailed Summary

This is a prospective, non-randomized, open-label clinical investigation to evaluate feasibility, effectiveness and safety of the PillSense System, the transit of the PillSense Capsule through the GI tract, patient tolerability of the PillSense Capsule, and blood detection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUGI Bleed, Upper Gastrointestinal Bleeding, Upper Gastrointestinal Bleed
CountriesUnited States
CollaboratorsDatabean

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMay 23, 2022
Enrollment StartDec 10, 2021
Primary CompletionSep 7, 2022
Study CompletionSep 13, 2022
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 4.1 years ago

Interventions

PillSenseother

The PillSense System is intended to detect the presence of blood in the stomach for the evaluation of upper gastrointestinal bleeding.