Back to resultsClinical Evaluation of the Safety and Performance of Microwave Coagulation Using the HS1 Instrument
Primary Purpose
Actual or Potential Nonvariceal Bleeding in the Upper Gastrointestinal (GI) Tract
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Microwave coagulation using HS1 Instrument
Sponsored by
About this trial
This is an interventional treatment trial for Actual or Potential Nonvariceal Bleeding in the Upper Gastrointestinal (GI) Tract
Eligibility Criteria
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
Sites / Locations
- East Kent Hospitals University Nhs Foundation Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patients receiving microwave therapy using the HS1 Instrument
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Identification and incidence of intra-procedural complications
Identification and incidence of post-procedural complications
Change in Glasgow-Blatchford score
The Glasgow-Blatchford score will be recorded prior to and after microwave intervention
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04406116
Brief Title
Clinical Evaluation of the Safety and Performance of Microwave Coagulation Using the HS1 Instrument
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2020 (Anticipated)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Creo Medical Limited
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actual or Potential Nonvariceal Bleeding in the Upper Gastrointestinal (GI) Tract
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patients receiving microwave therapy using the HS1 Instrument
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Microwave coagulation using HS1 Instrument
Intervention Description
Microwave therapy at 5.8 GHz
Primary Outcome Measure Information:
Title
Effective coagulation of of actual or potential non-variceal bleeding in the upper Gastrointestinal (GI) tract.
Description
Primary haemostasis at day 0 using microwave coagulation of active bleeding or pre-coagulation of exposed vessels.
Time Frame
Perioperative
Secondary Outcome Measure Information:
Title
Identification and incidence of intra-procedural complications
Time Frame
Day 0
Title
Identification and incidence of post-procedural complications
Time Frame
At 24-72 hours, 1 week and 4 weeks
Title
Change in Glasgow-Blatchford score
Description
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.
Other Pre-specified Outcome Measures:
Title
Questionnaire assessment of device injection features
Description
Endoscopist assessment of injection functionality (questionnaire)
Time Frame
Perioperative
Title
Questionnaire assessment of device adhesion characteristics
Description
Endoscopist assessment of tissue sticking (questionnaire)
Time Frame
Perioperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
dan crocker
Phone
+44 1291 606005
Email
dan.crocker@creomedical.com
Facility Information:
Facility Name
East Kent Hospitals University Nhs Foundation Trust
City
Canterbury
State/Province
Kent
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zacharias P Tsiamoulos, MBBS, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Evaluation of the Safety and Performance of Microwave Coagulation Using the HS1 Instrument
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