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Diagnostic Test

PillSense (Active) for Upper Gastrointestinal Bleed

N/A
Waitlist Available
Research Sponsored by EnteraSense Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 through day 14
Awards & highlights

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.

Eligible Conditions
  • Upper Gastrointestinal Bleed
  • Upper Gastrointestinal Bleeding

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through day 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through day 14 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sensitivity
Specificity
Secondary outcome measures
NPV
PPV
Transit

Trial Design

1Treatment groups
Experimental Treatment
Group I: PillSense (Active)Experimental Treatment1 Intervention
This is a single-arm, non-randomized study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PillSense
2021
N/A
~140

Find a Location

Who is running the clinical trial?

DatabeanIndustry Sponsor
4 Previous Clinical Trials
201 Total Patients Enrolled
EnteraSense LimitedLead Sponsor
2 Previous Clinical Trials
40 Total Patients Enrolled
David CollinsStudy DirectorTechnical Operations Director

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
PillSense System for Detecting UGI Bleed
2021. "PillSense System for Detecting UGI Bleed". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05385224.
~39 spots leftby Apr 2025
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