Status:
COMPLETED
PillSense System for Detecting UGI Bleed
Lead Sponsor:
EnteraSense Limited
Collaborating Sponsors:
Databean
Conditions:
UGI Bleed
Upper Gastrointestinal Bleeding
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
Patient eligibility as set out in the inclusion/exclusion criteria for the clinical investigation will be reviewed prior to study enrollment. Prior to administering the PillSense Capsule, the PillSens...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 13 2022
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT05385224
Start Date
December 10 2021
End Date
September 13 2022
Last Update
October 26 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic
Rochester, Minnesota, United States, 55905