Actual or Potential Nonvariceal Bleeding in the Upper Gastrointestinal (GI) Tract
Conditions
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
Interventions
DEVICEMicrowave coagulation using HS1 Instrument
Microwave therapy at 5.8 GHz
Sponsors
Creo Medical Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effective coagulation of of actual or potential non-variceal bleeding in the upper Gastrointestinal (GI) tract. | Perioperative | Primary haemostasis at day 0 using microwave coagulation of active bleeding or pre-coagulation of exposed vessels. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | The Glasgow-Blatchford score will be recorded prior to and after microwave intervention |
Other
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire assessment of device injection features | Perioperative | Endoscopist assessment of injection functionality (questionnaire) |
| Questionnaire assessment of device adhesion characteristics | Perioperative | Endoscopist assessment of tissue sticking (questionnaire) |
Countries
United Kingdom
Contacts
Primary Contactdan crocker
Outcome results
None listed