N/A
N=131
PillSense System for Detecting UGI Bleed
UGI Bleed · Upper Gastrointestinal Bleeding · Upper Gastrointestinal Bleed
Bottom Line
View on ClinicalTrials.gov: NCT05385224 ↗Enrolled (actual)
131
Serious AEs
11.9%
Results posted
Oct 2023
Primary outcome: Primary: Sensitivity — 26 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PillSense (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- EnteraSense Limited
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity |
26 | — |
| PRIMARY Specificity |
87 | — |
| SECONDARY NPV |
87 | — |
| SECONDARY Transit |
3.6 | — |
| SECONDARY PPV |
26 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05385224). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.