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

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

Official title:

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 Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04406116
• Other study ID #: 8-HS1-031PRO
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2020
• Est. completion date: June 2021

Study information

• Verified date: July 2020
• Source: Creo Medical Limited
• Contact: dan crocker
• Phone: +44 1291 606005
• Email: dan.crocker[@]creomedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 35
• Est. completion date: June 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Microwave coagulation using HS1 Instrument
Microwave therapy at 5.8 GHz

Locations

Country	Name	City	State
United Kingdom	East Kent Hospitals University Nhs Foundation Trust	Canterbury	Kent

Sponsors (1)

Lead Sponsor	Collaborator
Creo Medical Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Questionnaire assessment of device injection features	Endoscopist assessment of injection functionality (questionnaire)	Perioperative
Other	Questionnaire assessment of device adhesion characteristics	Endoscopist assessment of tissue sticking (questionnaire)	Perioperative
Primary	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	Identification and incidence of intra-procedural complications		Day 0
Secondary	Identification and incidence of post-procedural complications		At 24-72 hours, 1 week and 4 weeks
Secondary	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.