Study Stopped
Slow recruitment
Resolution Endoclips Vs Epinephrine Injection and Heater Probe
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
1 other identifier
interventional
103
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2005
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 14, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedMay 13, 2013
May 1, 2013
2.6 years
September 12, 2005
May 10, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
30 days
Secondary Outcomes (5)
Transfusion requirement (before and after endoscopic therapy)
within 30 days of therapy
Hospital stay
within 30 days of therapy
The need for surgery
within 30 days of therapy
Mortality from recurrent bleeding and all causes within 30 days of treatment
within 30 days of therapy
Treatment related complications e.g. perforation
within 30 days of therapy
Study Arms (2)
DUAL THERAPY
NO INTERVENTIONDUAL THERAPY
'Resolution clip
EXPERIMENTAL'Resolution clip
Interventions
Eligibility Criteria
You may qualify if:
- Age \>16 , can obtain written consent
- Ulcers that require endoscopic therapy with SRH: Forrest I a, Ib, II a and II b
You may not qualify if:
- Moribund patients with terminal malignancy
- Pregnancy
- Intercurrent ulcer complication that prevents treatment and surgery becomes mandatory such as bulbar stenosis and ulcer perforation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Endocopy Center, Prince of Wales Hospital
Hong Kong SAR, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Justin C Wu, MD
Endoscopy Center, Prince of Wales Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 14, 2005
Study Start
June 1, 2005
Primary Completion
January 1, 2008
Study Completion
November 1, 2008
Last Updated
May 13, 2013
Record last verified: 2013-05