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

NCT ID: NCT04406116

Last Updated: 2020-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-30

Study Completion Date

2021-06-30

Brief Summary

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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

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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patients receiving microwave therapy using the HS1 Instrument

Group Type EXPERIMENTAL

Microwave coagulation using HS1 Instrument

Intervention Type DEVICE

Microwave therapy at 5.8 GHz

Interventions

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Microwave coagulation using HS1 Instrument

Microwave therapy at 5.8 GHz

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Creo Medical Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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East Kent Hospitals University Nhs Foundation Trust

Canterbury, Kent, United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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dan crocker

Role: CONTACT

+44 1291 606005

Other Identifiers

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8-HS1-031PRO

Identifier Type: -

Identifier Source: org_study_id

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