Clinical Evaluation of the Safety and Performance of Microwave Coagulation Using the HS1 Instrument

Not Applicable

• Conditions: Actual or Potential Nonvariceal Bleeding in the Upper Gastrointestinal (GI) Tract
• Interventions: Device: Microwave coagulation using HS1 Instrument

• Registration Number: NCT04406116
• Lead Sponsor: Creo Medical Limited

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-20
• Study First Submitted QC: 2020-05-26
• Study First Posted: 2020-05-28
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-15
• Last Update Posted: 2020-07-17
• Study Start: 2020-09
• Primary Completion: 2021-04
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients receiving microwave therapy using the HS1 Instrument	Microwave coagulation using HS1 Instrument	-

Primary Outcome Measures

Name	Time	Method
Effective coagulation of of actual or potential non-variceal bleeding in the upper Gastrointestinal (GI) tract.	Perioperative	Primary haemostasis at day 0 using microwave coagulation of active bleeding or pre-coagulation of exposed vessels.

Secondary Outcome Measures

Name	Time	Method
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.	The Glasgow-Blatchford score will be recorded prior to and after microwave intervention

Trial Locations

Locations (1)

East Kent Hospitals University Nhs Foundation Trust; 🇬🇧 Canterbury, Kent, United Kingdom