Status:
UNKNOWN
Clinical Evaluation of the Safety and Performance of Microwave Coagulation Using the HS1 Instrument
Lead Sponsor:
Creo Medical Limited
Conditions:
Actual or Potential Nonvariceal Bleeding in the Upper Gastrointestinal (GI) Tract
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Clinical evaluation of the safety and performance of microwave coagulation using the HS1 Instrument for actual or potential non-variceal bleeding in the upper Gastrointestinal (GI) tract
Eligibility Criteria
Inclusion
- Patient or authorised representative able to comprehend and sign the Informed Consent form.
- Actual or potential non-variceal bleeding in the upper GI, including angiodysplasia or AVM malformations such as Dieulafoy's lesion with a Glasgow-Blatchford score of greater than 1
Exclusion
- As stated in the contraindications in the HS1 IFU;
- Aged \<18 years of age
- Those described as vulnerable populations in EN ISO 14155;
- Patients with a known coagulopathy (congenital);
- Concurrent participation in another experimental intervention or drug study
- Unwilling or unable to provide informed consent.
- A patient whose Glasgow-Blatchford score is 1 or less
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04406116
Start Date
September 1 2020
End Date
June 1 2021
Last Update
July 17 2020
Active Locations (1)
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1
East Kent Hospitals University Nhs Foundation Trust
Canterbury, Kent, United Kingdom