Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00165009
Status:
TERMINATED
Last Update Posted:
2013-05-13
First Post:
2005-09-12
Brief Title:
Resolution Endoclips Vs Epinephrine Injection and Heater Probe
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To compare the efficacy of a novel endoscopic clipping deviceResolution 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 32mm 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None