CompletedNot Applicable

PillSense System for Detecting UGI Bleed

United States131 participantsStarted 2021-12-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria * Age \>=18 years * Ability to provide informed consent * Clinical suspicion of UGIB Exclusion Criteria: * Circulatory or hemodynamic instability * Known GI tract stricture * Using an implantable electrical device * Difficulties in swallowing pills the size of the capsule * History of: achalasia or known esophageal dysmotility; gastroparesis; severe constipation; Crohn's disease; bowel obstruction * Currently taking medications intended for stimulation of GI motility * Currently pregnant or breastfeeding, or intend to become pregnant during the investigation * Suspected or previously diagnosed obstructing gastrointestinal tumor

What they're measuring

Sensitivity

Timeframe: Day 1

Specificity

Timeframe: Day 1

Trial details

NCT IDNCT05385224

SponsorEnteraSense Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-09-07

Results submitted2023-09-07

View on ClinicalTrials.gov More UGI Bleed trials