Clinical Evaluation of the Safety and Performance of Microwave Coagulation Using the HS1 Instrument
1 other identifier
interventional
35
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2020
CompletedFirst Posted
Study publicly available on registry
May 28, 2020
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedJuly 17, 2020
July 1, 2020
7 months
May 20, 2020
July 15, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Day 0 for initial screen and then 24-72 hours post-procedure for second score.
Other Outcomes (2)
Questionnaire assessment of device injection features
Perioperative
Questionnaire assessment of device adhesion characteristics
Perioperative
Study Arms (1)
patients receiving microwave therapy using the HS1 Instrument
EXPERIMENTALInterventions
Microwave therapy at 5.8 GHz
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
East Kent Hospitals University Nhs Foundation Trust
Canterbury, Kent, United Kingdom
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2020
First Posted
May 28, 2020
Study Start
September 1, 2020
Primary Completion
April 1, 2021
Study Completion
June 1, 2021
Last Updated
July 17, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share