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

Creo Medical

Status: Unknown

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

Treatments: Device: Microwave coagulation using HS1 Instrument

Study type: Interventional

Funder types: Industry

Identifiers

NCT04406116

8-HS1-031PRO

Details and patient eligibility

About

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

Enrollment: 35 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

patients receiving microwave therapy using the HS1 Instrument

Experimental group

Treatment:

Device: Microwave coagulation using HS1 Instrument