Actual or Potential Nonvariceal Bleeding in the Upper Gastrointestinal (GI) TractNCT04406116
Clinical Evaluation of the Safety and Performance of Microwave Coagulation Using the HS1 Instrument
A study testing Microwave coagulation using HS1 Instrument in people with Actual or Potential Nonvariceal Bleeding in the Upper Gastrointestinal (GI) Tract, run by Creo Medical Limited at 1 site in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actual or Potential Nonvariceal Bleeding in the Upper Gastrointestinal (GI) Tract
- What is being tested?
- Microwave coagulation using HS1 Instrument
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2020to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
East Kent Hospitals University Nhs Foundation Trust
Canterbury, Kent
Zacharias P Tsiamoulos, MBBS, PhD
About this study
Official 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
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
- Being tested
- Microwave coagulation using HS1 Instrument
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microwave coagulation using HS1 InstrumentDevice
Microwave therapy at 5.8 GHz
| Study group | Role | What they receive |
|---|---|---|
| patients receiving microwave therapy using the HS1 Instrument | Experimental | Not described Receives: Device: Microwave coagulation using HS1 Instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Perioperative
Secondary outcomes (3)
Identification and incidence of intra-procedural complications
Measured: Day 0
Identification and incidence of post-procedural complications
Measured: At 24-72 hours, 1 week and 4 weeks
Change in Glasgow-Blatchford score
The Glasgow-Blatchford score will be recorded prior to and after microwave intervention
Measured: Day 0 for initial screen and then 24-72 hours post-procedure for second score.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study startSep 2020 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actual or Potential Nonvariceal Bleeding in the Upper Gastrointestinal (GI) TractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Creo Medical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406116
- Sponsor's protocol ID
- 8-HS1-031PRO
- Status last verified
- Jul 2020
- First submitted
- 20 May 2020
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04406116
- Acronym / sponsor ID
- 8-HS1-031PRO
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Creo Medical LimitedIndustry (pharma, biotech, devices)
- Study start
- Sep 2020 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients receiving microwave therapy using the HS1 Instrument | Experimental | Device: Microwave coagulation using HS1 Instrument |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microwave coagulation using HS1 InstrumentMicrowave therapy at 5.8 GHz | Device | patients receiving microwave therapy using the HS1 Instrument |
Primary outcome
Effective coagulation of of actual or potential non-variceal bleeding in the upper Gastrointestinal (GI) tract.
Time frame: Perioperative
Primary haemostasis at day 0 using microwave coagulation of active bleeding or pre-coagulation of exposed vessels.
3 secondary outcomes
Identification and incidence of intra-procedural complications
Time frame: Day 0
Identification and incidence of post-procedural complications
Time frame: At 24-72 hours, 1 week and 4 weeks
Change in Glasgow-Blatchford score
Time frame: Day 0 for initial screen and then 24-72 hours post-procedure for second score.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microwave coagulation using HS1 Instrument in people with Actual or Potential Nonvariceal Bleeding in the Upper Gastrointestinal (GI) Tract, run by Creo Medical Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact dan crocker (+44 1291 606005, dan.crocker@creomedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective coagulation of of actual or potential non-variceal bleeding in the upper Gastrointestinal (GI) tract. (time frame: Perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2020.