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NCT05385224 · ClinicalTrials.gov registry record · NA
PillSense System for Detecting UGI Bleed
A NA study of UGI Bleed and Upper Gastrointestinal Bleeding, sponsored by EnteraSense Limited.
- Completed
- Registry status
- NA
- Development phase
- 131
- Enrollment target
- 1
- Study location
NCT05385224: Completed NA study of UGI Bleed and Upper Gastrointestinal Bleeding, sponsored by EnteraSense Limited.
NCT05385224 is a NA study of UGI Bleed and Upper Gastrointestinal Bleeding that has completed, run by EnteraSense Limited. The registered enrollment target is 131 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05385224, a NA study of UGI Bleed and Upper Gastrointestinal Bleeding, has completed, sponsored by EnteraSense Limited.
- COMPLETED
- Registry status
- NA
- Development phase
- 131 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST PillSense
Study Locations (1)
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2021-12-10 |
| Est. Completion | 2022-09-13 |
| Phase | NA |
What the finished NCT05385224 record still lists
NCT05385224 is an interventional study that assigns participants to a tested intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 3 conditions, with UGI Bleed appearing as the primary indexed condition, and to 1 intervention - of which PillSense is the first listed.
NCT05385224 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT05385224 about?
NCT05385224 is a clinical study titled "PillSense System for Detecting UGI Bleed". 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.
What is the current status of trial NCT05385224?
This trial is currently completed. It is a NA study. The enrollment target is 131 participants. The study started on 2021-12-10. Estimated completion is 2022-09-13.
What conditions does trial NCT05385224 study?
This clinical trial studies the following conditions: UGI Bleed, Upper Gastrointestinal Bleeding, Upper Gastrointestinal Bleed.
What interventions are being tested in trial NCT05385224?
The interventions under investigation include: PillSense (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05385224?
This trial is sponsored by EnteraSense Limited, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05385224 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05385224's enrollment target sits among peer trials
131 732nd of 2000 higher than 1,268 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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