Peptic Ulcer HemorrhagePhase 3NCT00165009
Resolution Endoclips Vs Epinephrine Injection and Heater Probe
A Phase 3 study testing Resolution clip (endo-clipping device) in people with Peptic Ulcer Hemorrhage, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
To compare the efficacy of a novel endoscopic clipping device(Resolution Clip™) and conventional epinephrine injection and heater probe thermocoagulation in control of peptic ulcer bleeding and prevention of recurrent bleeding Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Peptic Ulcer Hemorrhage
- What is being tested?
- Resolution clip (endo-clipping device)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteChina
- Study dates
- Jun 2005to Nov 2008
- Phase
- Phase 3
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age >16 , can obtain written consent
- Ulcers that require endoscopic therapy with SRH: Forrest I a, Ib, II a and II b
Who cannot join
- Moribund patients with terminal malignancy
- Pregnancy
- Intercurrent ulcer complication that prevents treatment and surgery becomes mandatory such as bulbar stenosis and ulcer perforation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Comparison of a Novel Hemostatic Clip (Resolution Clip™) to Combined Epinephrine Injection and Heater Probe Thermocoagulation in the Endoscopic Control of Ulcer Bleeding
To compare the efficacy of a novel endoscopic clipping device(Resolution Clip™) and conventional epinephrine injection and heater probe thermocoagulation in control of peptic ulcer bleeding and prevention of recurrent bleeding
Read the detailed description
The mortality of peptic ulcer bleeding remains high despite advances in endoscopy and medical therapy. Endoscopic therapy effectively controls peptic ulcer bleeding and substantially reduces recurrent bleeding. However, the best endoscopic therapy is still unclear. The current standard of therapy is injection with diluted epinephrine and heater probe (3.2mm) thermo-coagulation. However, it may be associated with complications such as precipitation of myocardial ischemia or heater probe perforation.
Endoscopic clipping is an emerging modality of endoscopic treatment, it mimics the use of surgical ligature on bleeding artery. Endo-clipping has the theoretical advantage over injection and heater probe in that the tissue reaction or damage will be much milder.
Resolution Clip™ is a newly developed endo-clipping device. It is superior to older generations of endo-clips in that it allows repeated closures and re-opening of clip so as to facilitate accurate deployment onto bleeding artery to ensure its optimal placement for hemostasis.
Consecutive patients with endoscopically confirmed bleeding peptic ulcer will be invited to participate in this double-blind, randomised trial, which compares the efficacy of Resolution clip and conventional dual endoscopic therapy. Patients will be compared for 30-day treatment failure rate.
- Conditions
- Peptic Ulcer Hemorrhage
- Being tested
- Resolution clip (endo-clipping device)
- Keywords
- Bleeding Peptic Ulcer, Endoscopic treatment
- Medical subject headings
- Peptic Ulcer Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resolution clip (endo-clipping device)Device
Resolution clip (endo-clipping device)
| Study group | Role | What they receive |
|---|---|---|
| DUAL THERAPY | No intervention | DUAL THERAPY |
| 'Resolution clip | Experimental | 'Resolution clip Receives: Device: Resolution clip (endo-clipping device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure to control bleeding endoscopically and recurrent bleeding after initial control
linical rebleeding is defined by fresh hematemesis, fresh melena or hematochezia and signs of hypovolemic shock (systolic blood pressure of <90mmHg and pulse rate >110 per minute) and a drop in hemoglobin of > 2 g/dl per 24 hours despite adequate transfusion.
Rebleeding will be confirmed by an immediate endoscopy showing fresh blood in stomach or active bleeding from a previously seen ulcer. A clinical rebleeding will be independently reviewed by an adjudication panel.
Measured: 30 days
Secondary outcomes (5)
Transfusion requirement (before and after endoscopic therapy)
Measured: within 30 days of therapy
Hospital stay
Measured: within 30 days of therapy
The need for surgery
Measured: within 30 days of therapy
Mortality from recurrent bleeding and all causes within 30 days of treatment
Measured: within 30 days of therapy
Treatment related complications e.g. perforation
Measured: within 30 days of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionJan 2008
- Study completionNov 2008
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peptic Ulcer HemorrhageStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Yun-wong Lau, Chinese University of Hong Kong
- Investigators
- Justin C Wu, MD, Principal investigator, Endoscopy Center, Prince of Wales Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00165009
- Sponsor's protocol ID
- RET
- Status last verified
- May 2013
- First submitted
- 12 Sep 2005
- Last updated
- 13 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Comparison of a Novel Hemostatic Clip (Resolution Clip™) to Combined Epinephrine Injection and Heater Probe Thermocoagulation in the Endoscopic Control of Ulcer Bleeding
- ClinicalTrials.gov ID
- NCT00165009
- Acronym / sponsor ID
- RET
- Conditions
- Peptic Ulcer Hemorrhage
- Keywords
- Bleeding Peptic Ulcer, Endoscopic treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 14 Sep 2005 (estimated)
- 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.
To compare the efficacy of a novel endoscopic clipping device(Resolution Clip™) and conventional epinephrine injection and heater probe thermocoagulation in control of peptic ulcer bleeding and prevention of recurrent bleeding
Detailed description
The mortality of peptic ulcer bleeding remains high despite advances in endoscopy and medical therapy. Endoscopic therapy effectively controls peptic ulcer bleeding and substantially reduces recurrent bleeding. However, the best endoscopic therapy is still unclear. The current standard of therapy is injection with diluted epinephrine and heater probe (3.2mm) thermo-coagulation. However, it may be associated with complications such as precipitation of myocardial ischemia or heater probe perforation.
Endoscopic clipping is an emerging modality of endoscopic treatment, it mimics the use of surgical ligature on bleeding artery. Endo-clipping has the theoretical advantage over injection and heater probe in that the tissue reaction or damage will be much milder.
Resolution Clip™ is a newly developed endo-clipping device. It is superior to older generations of endo-clips in that it allows repeated closures and re-opening of clip so as to facilitate accurate deployment onto bleeding artery to ensure its optimal placement for hemostasis.
Consecutive patients with endoscopically confirmed bleeding peptic ulcer will be invited to participate in this double-blind, randomised trial, which compares the efficacy of Resolution clip and conventional dual endoscopic therapy. Patients will be compared for 30-day treatment failure rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DUAL THERAPY | No intervention | –DUAL THERAPY |
| 'Resolution clip | Experimental | Device: Resolution clip (endo-clipping device)'Resolution clip |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age >16 , can obtain written consent
- Ulcers that require endoscopic therapy with SRH: Forrest I a, Ib, II a and II b
Key exclusion criteria (3 listed)
- Moribund patients with terminal malignancy
- Pregnancy
- Intercurrent ulcer complication that prevents treatment and surgery becomes mandatory such as bulbar stenosis and ulcer perforation
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 |
|---|---|---|
| Resolution clip (endo-clipping device)Resolution clip (endo-clipping device) | Device | 'Resolution clip |
Primary outcome
Failure to control bleeding endoscopically and recurrent bleeding after initial control
Time frame: 30 days
linical rebleeding is defined by fresh hematemesis, fresh melena or hematochezia and signs of hypovolemic shock (systolic blood pressure of <90mmHg and pulse rate >110 per minute) and a drop in hemoglobin of > 2 g/dl per 24 hours despite adequate transfusion. Rebleeding will be confirmed by an immediate endoscopy showing fresh blood in stomach or active bleeding from a previously seen ulcer. A clinical rebleeding will be independently reviewed by an adjudication panel.
5 secondary outcomes
Transfusion requirement (before and after endoscopic therapy)
Time frame: within 30 days of therapy
Hospital stay
Time frame: within 30 days of therapy
The need for surgery
Time frame: within 30 days of therapy
Mortality from recurrent bleeding and all causes within 30 days of treatment
Time frame: within 30 days of therapy
Treatment related complications e.g. perforation
Time frame: within 30 days of therapy
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2013.
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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.
Justin C Wu, MD principal investigator
Endoscopy Center, Prince of Wales Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Resolution clip (endo-clipping device) in people with Peptic Ulcer Hemorrhage, run by Chinese University of Hong Kong at 1 site in China.
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 3 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: stopped early, as of the sponsor's last update on 13 May 2013. 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 China. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure to control bleeding endoscopically and recurrent bleeding after initial control (time frame: 30 days). 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 13 May 2013.