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

Creo Medical Limited35 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Actual or Potential Nonvariceal Bleeding in the Upper Gastrointestinal (GI) Tract

Interventions

Microwave coagulation using HS1 InstrumentDEVICE

Microwave therapy at 5.8 GHz

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

East Kent Hospitals University Nhs Foundation Trust

Canterbury, Kent, United Kingdom

Outcomes

Primary Outcomes

Effective coagulation of of actual or potential non-variceal bleeding in the upper Gastrointestinal (GI) tract.

Primary haemostasis at day 0 using microwave coagulation of active bleeding or pre-coagulation of exposed vessels.

Time frame: Perioperative

Secondary Outcomes

Identification and incidence of intra-procedural complications

Time frame: Day 0

Identification and incidence of post-procedural complications

Time frame: At 24-72 hours, 1 week and 4 weeks

Change in Glasgow-Blatchford score

The Glasgow-Blatchford score will be recorded prior to and after microwave intervention

Time frame: Day 0 for initial screen and then 24-72 hours post-procedure for second score.

Central Contacts

dan crocker

CONTACT

+44 1291 606005 dan.crocker@creomedical.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.