NCT04406116UnknownNot Applicable
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
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Creo Medical Limited
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Effective coagulation of of actual or potential non-variceal bleeding in the upper Gastrointestinal (GI) tract.
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Effective coagulation of of actual or potential non-variceal bleeding in the upper Gastrointestinal (GI) tract.
Time Frame: Perioperative
Primary haemostasis at day 0 using microwave coagulation of active bleeding or pre-coagulation of exposed vessels.
Secondary Outcomes
- Identification and incidence of intra-procedural complications(Day 0)
- Identification and incidence of post-procedural complications(At 24-72 hours, 1 week and 4 weeks)
- Change in Glasgow-Blatchford score(Day 0 for initial screen and then 24-72 hours post-procedure for second score.)
Investigators
Study Sites (1)
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