Performance of microwave coagulation using the HS1 Instrument
Research type
Research Study
Full 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
IRAS ID
279488
Contact name
Zacharias P Tsiamoulos
Contact email
Sponsor organisation
Creo Medical Limited
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 8 months, 2 days
Research summary
The most common clinical emergency in the upper gastrointestinal (GI) tract is an acute bleed. In the UK, approximately 85,000 cases per year with 4000 death annually (or 10%) require emergency medical attention due to an acute GI bleed. The cost to the NHS for treating acute upper GI bleeds is estimated at £155 million annually, over 60% (£93 million) is spent on hospital stay, 25% (£38.5 million) on endoscopy treatment and 8% (£12.6 million) on blood transfusions.
The HS1 instrument received CE marking based on its equivalence (In accordance with MEDDEV 2.7/1 revision 4) to the Speedboat RS2 in the lower GI. When the clinical evaluation was reviewed in the context of the upper GI, BSI determined that more clinical data was required to support the use of the microwave energy at 5.8 GHz.
The next stage is to perform a human clinical trial in 35 patients to demonstrate that 1) our device will effectively seal any bleeding blood vessel or ulcer in the GI tract 2) cause no harm to the patient either during or after the procedure.
Patient who present at the Queen Elizabeth the Queen Mother (QEQM) Hospital, with GI bleeding will be recruited into the study. Patients will be initially treated using the HS1 device (two attempts will be made), in the unlikely event that the bleed can not be effectively sealed, Dr Tsiamoulos (Chief investigator) will switch to the standard clinical practice to complete the task. Patients will be monitored for 24-72 hours and any adverse events recorded. A follow up assessment will be conducted at 1 & 4 weeks post-surgery.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
20/WM/0212
Date of REC Opinion
17 Sep 2020
REC opinion
Further Information Favourable Opinion