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

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

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 Overview

• Status: Unknown
• Conditions: Actual or Potential Nonvariceal Bleeding in the Upper Gastrointestinal (GI) Tract
• Intervention / Treatment: Device: Microwave coagulation using HS1 Instrument

• Study Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: dan crocker; Phone Number: +44 1291 606005; Email: dan.crocker@creomedical.com

Study Locations

• United Kingdom
  • Kent
    • Canterbury, Kent, United Kingdom
      • East Kent Hospitals University NHS Foundation Trust
      • Principal Investigator: Zacharias P Tsiamoulos, MBBS, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients receiving microwave therapy using the HS1 Instrument	Device: Microwave coagulation using HS1 Instrument; Microwave therapy at 5.8 GHz

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Perioperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The Glasgow-Blatchford score will be recorded prior to and after microwave intervention	Day 0 for initial screen and then 24-72 hours post-procedure for second score.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire assessment of device injection features	Endoscopist assessment of injection functionality (questionnaire)	Perioperative
Questionnaire assessment of device adhesion characteristics	Endoscopist assessment of tissue sticking (questionnaire)	Perioperative

Collaborators and Investigators

• Sponsor: Creo Medical Limited

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: May 20, 2020
• First Submitted That Met QC Criteria: May 26, 2020
• First Posted (Actual): May 28, 2020

Study Record Updates

• Last Update Posted (Actual): July 17, 2020
• Last Update Submitted That Met QC Criteria: July 15, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: 8-HS1-031PRO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No