Standard Endoscopic Hemostasis Versus OVESCO Severe Non-variceal UGI Hemorrhage
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|ClinicalTrials.gov Identifier: NCT03065465|
Recruitment Status : Recruiting
First Posted : February 28, 2017
Last Update Posted : July 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Upper Gastrointestinal Hemorrhage||Device: Over-the-scope hemoclipping device Other: Standard endoscopic treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomized Controlled Trial (RCT) of Standard Endoscopic Hemostasis Compared to OVESCO for Severe Non-variceal UGI Hemorrhage|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||July 2019|
Standard endoscopic treatment
For those assigned to the standard endoscopy group, endoscopic hemostasis will be performed using usual Center for Ulcer Research and Education (CURE) hemostasis therapy for the focal GI lesions: injection of dilute (e.g. 1:20,000) epinephrine (in 1-2 cc aliquots in 4 quadrants next to the stigmata of recent hemorrhage - SRH), coaptive coagulation with multipolar electrocautery (MPEC) probe, and/or standard through the endoscope hemoclips along the course of the underlying artery as detected by Doppler endoscopic probe (DEP). Hemostasis will be performed until active bleeding stops and/or the SRH is obliterated.
Other: Standard endoscopic treatment
Standard therapy includes injection of dilute epinephrine, thermal coagulation with multipolar electrocautery (MPEC) probe, and/or hemoclips.
Experimental: Over-the-scope hemoclipping device
For those assigned OTSC, the device will be used according to manufacturer instructions. Once the endoscopic diagnosis is made, the endoscope will be removed and affixed with the OTSC of appropriate size for the endoscope and the lesion in question. The endoscope will be re-introduced to the bleeding site. The SRH will be centered in the field of view and within the cap of the OTSC deployment device. The lesion and SRH will be captured into the cap and the OTSC will be deployed by rotating the handle and thereby compressing the bleeding lesion and surrounding tissue for mechanical hemostasis. If initial deployment is unsuccessful due to technical factors or if hemostasis is not achieved, a second deployment will be allowed.
Device: Over-the-scope hemoclipping device
A endoscopic entrapment of tissue for control of bleeding or other applications.
Other Name: OVESCO clip
- The rebleeding rate of non-variceal focal UGI lesions [ Time Frame: Outcome measure will be assessed at 30 days after participants are enrolled ]The investigators will compare the rebleeding rate at 30 days follow up in the two treatment groups.
- Obliteration rates of underlying arterial blood flow (detected by Doppler endoscopic probe) [ Time Frame: Outcome measure will be assessed at 30 days after the endoscopy treatment is completed ]The investigators will use the Doppler endoscopic probe to measure the blood flow before and after the application of over-the-hemoclipping device and standard endoscopic hemostasis.
- Rates of surgery or IR, complications, cross-over to other endoscopic treatment and death [ Time Frame: Outcome measure will be assessed at 30 days after participants are enrolled ]The investigators will compare the rates of surgery or IR, complications, and death at 30 days for the two treatment groups.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03065465
|Contact: Dennis M Jensen, MDfirstname.lastname@example.org|
|Contact: Kwanmanus N Suvanamas, BS||310-478-3711 ext email@example.com|
|United States, California|
|VA Greater Los Angeles Healthcare System||Recruiting|
|Los Angeles, California, United States, 90073|
|Contact: Dennis M Jensen, MD 310-268-3569 firstname.lastname@example.org|
|Contact: Kwanmanus N Suvanamas, BS 310-478-3711 ext 43324 email@example.com|
|Principal Investigator: Dennis M Jensen, MD|
|University of California, Los Angeles||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Dennis M Jensen, MD 310-268-3569 firstname.lastname@example.org|
|Contact: Kwanmanus N Suvanamas, BS 310-478-3711 ext 43324 email@example.com|
|Principal Investigator: Dennis M Jensen, MD|
|Principal Investigator:||Dennis M Jensen, MD||University of California, Los Angeles|