Clinical Evaluation of the Safety and Performance of Microwave Coagulation Using the HS1 Instrument
NCT ID: NCT04406116
Last Updated: 2020-07-17
Study Results
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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UNKNOWN
NA
35 participants
INTERVENTIONAL
2020-09-30
2021-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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patients receiving microwave therapy using the HS1 Instrument
Microwave coagulation using HS1 Instrument
Microwave therapy at 5.8 GHz
Interventions
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Microwave coagulation using HS1 Instrument
Microwave therapy at 5.8 GHz
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Creo Medical Limited
INDUSTRY
Responsible Party
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Locations
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East Kent Hospitals University Nhs Foundation Trust
Canterbury, Kent, United Kingdom
Countries
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Central Contacts
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Other Identifiers
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8-HS1-031PRO
Identifier Type: -
Identifier Source: org_study_id
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