Upper Gastrointestinal HemorrhageNCT03065465
Standard Endoscopic Hemostasis Versus OVESCO Severe Non-variceal UGI Hemorrhage
A study testing Over-the-scope hemoclipping device and Standard endoscopic treatment in people with Upper Gastrointestinal Hemorrhage, run by CURE Digestive Diseases Research Center at 2 sites in United States.
Trial summary
The primary specific aim is to perform a randomized controlled trial (RCT) to compare 30 day rebleed rates and other clinical outcomes of patients with severe, non-variceal upper GI hemorrhage (NVUGIH) - ulcers and Dieulafoy's lesions who are randomized as initial treatment with the new large over-the-scope-clip… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Gastrointestinal Hemorrhage
- What is being tested?
- Over-the-scope hemoclipping device and Standard endoscopic treatment
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Nov 2015to 28 Feb 2025
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent from the patient or a surrogate.
- Clinical evidence of severe UGIB.
- Presence of a benign appearing peptic ulcer, anastomotic ulcer, or Dieulafoy's lesion, with some SRH on endoscopy.
- Severe upper GI bleeding.
- Life expectancy of at least 30 days based on lack of severe or terminal comorbidity as judged by the generalist or subspecialist caring for the patient.
Who cannot join
- Patients who are do-not-resuscitate (DNR) that is not reversible, uncooperative, refuse to participate, or are unable to give consent personally or through a legal surrogate.
- Active GI malignancy, under treatment but not in remission.
- Acute hypovolemic shock that is unresponsive to transfusion of 5 or more units of red blood cells (RBC's) or requires continuous intravenous vasopressor infusion for blood pressure support.
- ASA (American Society of Anesthesiology) class V or higher, moribund, or with a very poor prognosis and expected survival <30 days.
- Severe coagulopathy or thrombocytopenia despite attempted reversal with transfusion of blood products (e.g persistent International Normalized Ratio [INR] >2.0, platelet count <20,000, a Partial Thromboplastin Time [PTT] greater than 2x upper limit of normal).
- Absolute contraindication to urgent endoscopy (such as suspected perforated viscus, or peritonitis).
- Stricture of the esophagus or pylorus that can not be dilated or precludes passage of a diagnostic sized endoscope and/or the GI endoscope with an 11, 3a OTSC device attached.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073
Dennis M Jensen, MD, 310-268-3569, dennis.jensen@va.gov
Kwanmanus N Suvanamas, BS, 310-478-3711 ext. 43324, kwanmanus.suvanamas@va.gov
- Recruiting
University of California, Los Angeles
Los Angeles, California, 90095
Dennis M Jensen, MD, 310-268-3569, djensen@mednet.ucla.edu
Kwanmanus N Suvanamas, BS, 310-478-3711 ext. 43324, ksuvanamas@mednet.ucla.edu
About this study
Official title: Randomized Controlled Trial (RCT) of Standard Endoscopic Hemostasis Compared to OVESCO for Severe Non-variceal UGI Hemorrhage
The primary specific aim is to perform a randomized controlled trial (RCT) to compare 30 day rebleed rates and other clinical outcomes of patients with severe, non-variceal upper GI hemorrhage (NVUGIH) - ulcers and Dieulafoy's lesions who are randomized as initial treatment with the new large over-the-scope-clip device for endoscopic hemostasis versus standard endoscopic hemostasis.
Read the detailed description
Upper GI Hemorrhage (UGIH) causes significant morbidity and mortality, although endoscopic hemostasis has revolutionized management of these patients. Despite standard endoscopic treatment and high dose proton pump infusions, 25% - 30% of high risk patients with UGIB from ulcers or other non-variceal UGI lesions (NVUGI) had recurrent bleeding in a recent RCT and cohort studies by our group. Potential risk factors for NVUGI rebleeding were large ulcers (≥ 15 mm), fibrotic bases, Dieulafoy's lesions, anastomotic ulcers, coagulopathies, cirrhosis, other severe co-morbidities and residual arterial blood flow under stigmata of recent hemorrhage (SRH) after endoscopic treatment. Such patients with rebleeding after standard endoscopic hemostasis usually required angiography (by interventional radiologists-IR) or surgery for definitive hemostasis. A new, large, FDA approved, over-the-scope hemoclipping device (OTSC® System OVESCO Endoscopy, Tübingen, Germany) can capture larger amounts of tissue and underlying arteries than standard hemoclips and potentially can improve endoscopic hemostasis of such bleeding lesions.
- Conditions
- Upper Gastrointestinal Hemorrhage
- Being tested
- Over-the-scope hemoclipping device, Standard endoscopic treatment
- Keywords
- Upper GI hemorrhage, Stigmata of recent hemorrhage, Ulcers, Dieulafoy's lesions
- Medical subject headings
- Gastrointestinal Hemorrhage, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Over-the-scope hemoclipping deviceDevice
Also called OTSC clip
A endoscopic entrapment of tissue for control of bleeding or other applications.
Standard endoscopic treatmentOther
Standard therapy includes injection of dilute epinephrine, thermal coagulation with multipolar electrocautery (MPEC) probe, and/or hemoclips.
| Study group | Role | What they receive |
|---|---|---|
| Standard endoscopic treatment | Other | For those assigned to the standard endoscopy group, endoscopic hemostasis is performed using usual 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 SRH) of active bleeding or adherent clots (prior to snaring them off); coaptive coagulation with multipolar electrocautery (MPEC) probe and/or standard through the endoscope hemoclips along the course of the underlying artery as detected by DEP. Hemostasis is performed until active bleeding stops and/or the SRH is obliterated. Residual blood flow after visually guided hemostasis is recorded, but not used as a guide for additional hemostasis in this study. Receives: Other: Standard endoscopic treatment |
| Over-the-scope hemoclipping device | Experimental | For those assigned OTSC, prior to use of the OTSC in UGI lesions with active bleeding or adherent clots, dilute epinephrine (1: 20,000) is injected around the SRH in 1-2 cc aliquots and the clots are cold guillotined off, as previously described (2, 4, 17). As a brief additional description, after initial diagnosis and preparation of the lesion and SRH (as described for standard hemostasis), the therapeutic sized endoscope is removed and this or a diagnostic panendoscope will be affixed with the OTSC of appropriate size for the endoscope and the target lesion. The endoscope is re-introduced and passed to the bleeding site. The SRH is centered in the field of view and within the cap of the OTSC device. Using high suctioning and firm pressure to center the SRH, the lesion and SRH is captured into the cap and the OTSC is deployed by rotating the handle and thereby compressing the bleeding lesion and surrounding tissue with mechanical hemostasis. Receives: Device: Over-the-scope hemoclipping device |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rebleeding rate of non-variceal focal UGI lesions
The investigators will compare the rebleeding rate at 30 days follow up in the two treatment groups for all patients, ulcer patients only, and also patients with major stigmata of hemorrhage vs. lesser stigmata (oozing or flat spots).
Measured: Outcome measure will be assessed at 30 days after participants are enrolled
Secondary outcomes (2)
Obliteration rates of underlying arterial blood flow (detected by Doppler endoscopic probe)
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.
Measured: Outcome measure will be assessed at 30 days after the endoscopy treatment is completed
Rates of surgery or IR, complications, and death
The investigators will compare the rates of surgery or IR, complications, transfusion, hospital stays, and death at 30 days for the two treatment groups.
Measured: Outcome measure will be assessed at 30 days after participants are enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study start15 Nov 2015
- Primary completion24 Dec 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Upper Gastrointestinal HemorrhageStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CURE Digestive Diseases Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, VA Greater Los Angeles Healthcare System
- Responsible party
- Sponsor
- Investigators
- Dennis M Jensen, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03065465
- Sponsor's protocol ID
- OVESCO
- Status last verified
- Jan 2024
- First submitted
- 29 Nov 2016
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Laine L, Jensen DM. Management of patients with ulcer bleeding. Am J Gastroenterol. 2012 Mar;107(3):345-60; quiz 361. doi: 10.1038/ajg.2011.480. Epub 2012 Feb 7.
PubMed 22310222Camus M, Jensen DM, Kovacs TO, Jensen ME, Markovic D, Gornbein J. Independent risk factors of 30-day outcomes in 1264 patients with peptic ulcer bleeding in the USA: large ulcers do worse. Aliment Pharmacol Ther. 2016 May;43(10):1080-9. doi: 10.1111/apt.13591. Epub 2016 Mar 22.
PubMed 27000531Jensen DM, Kovacs TOG, Ohning GV, Ghassemi K, Machicado GA, Dulai GS, Sedarat A, Jutabha R, Gornbein J. Doppler Endoscopic Probe Monitoring of Blood Flow Improves Risk Stratification and Outcomes of Patients With Severe Nonvariceal Upper Gastrointestinal Hemorrhage. Gastroenterology. 2017 May;152(6):1310-1318.e1. doi: 10.1053/j.gastro.2017.01.042. Epub 2017 Feb 4.
PubMed 28167214Schmidt A, Golder S, Goetz M, Meining A, Lau J, von Delius S, Escher M, Hoffmann A, Wiest R, Messmann H, Kratt T, Walter B, Bettinger D, Caca K. Over-the-Scope Clips Are More Effective Than Standard Endoscopic Therapy for Patients With Recurrent Bleeding of Peptic Ulcers. Gastroenterology. 2018 Sep;155(3):674-686.e6. doi: 10.1053/j.gastro.2018.05.037. Epub 2018 May 24.
PubMed 29803838Nishiyama N, Mori H, Kobara H, Rafiq K, Fujihara S, Kobayashi M, Oryu M, Masaki T. Efficacy and safety of over-the-scope clip: including complications after endoscopic submucosal dissection. World J Gastroenterol. 2013 May 14;19(18):2752-60. doi: 10.3748/wjg.v19.i18.2752.
PubMed 23687412Monkemuller K, Peter S, Toshniwal J, Popa D, Zabielski M, Stahl RD, Ramesh J, Wilcox CM. Multipurpose use of the 'bear claw' (over-the-scope-clip system) to treat endoluminal gastrointestinal disorders. Dig Endosc. 2014 May;26(3):350-7. doi: 10.1111/den.12145. Epub 2013 Jul 16.
PubMed 23855514Kirschniak A, Kratt T, Stuker D, Braun A, Schurr MO, Konigsrainer A. A new endoscopic over-the-scope clip system for treatment of lesions and bleeding in the GI tract: first clinical experiences. Gastrointest Endosc. 2007 Jul;66(1):162-7. doi: 10.1016/j.gie.2007.01.034.
PubMed 17591492Manta R, Galloro G, Mangiavillano B, Conigliaro R, Pasquale L, Arezzo A, Masci E, Bassotti G, Frazzoni M. Over-the-scope clip (OTSC) represents an effective endoscopic treatment for acute GI bleeding after failure of conventional techniques. Surg Endosc. 2013 Sep;27(9):3162-4. doi: 10.1007/s00464-013-2871-1. Epub 2013 Feb 23.
PubMed 23436101Richter-Schrag HJ, Glatz T, Walker C, Fischer A, Thimme R. First-line endoscopic treatment with over-the-scope clips significantly improves the primary failure and rebleeding rates in high-risk gastrointestinal bleeding: A single-center experience with 100 cases. World J Gastroenterol. 2016 Nov 7;22(41):9162-9171. doi: 10.3748/wjg.v22.i41.9162.
PubMed 27895403Wedi E, von Renteln D, Gonzalez S, Tkachenko O, Jung C, Orkut S, Roth V, Tumay S, Hochberger J. Use of the over-the-scope-clip (OTSC) in non-variceal upper gastrointestinal bleeding in patients with severe cardiovascular comorbidities: a retrospective study. Endosc Int Open. 2017 Sep;5(9):E875-E882. doi: 10.1055/s-0043-105496. Epub 2017 Sep 12.
PubMed 28924593Golder S, Neuhas L, Freuer D, Probst A, Ebigbo A, Braun G, Brueckner J, Stueckle J, Meier A, Messmann H. Over-the-scope clip in peptic ulcer bleeding: clinical success in primary and secondary treatment and factors associated with treatment failure. Endosc Int Open. 2019 Jun;7(6):E846-E854. doi: 10.1055/a-0898-3357. Epub 2019 Jun 13.
PubMed 31206010Wedi E, Fischer A, Hochberger J, Jung C, Orkut S, Richter-Schrag HJ. Multicenter evaluation of first-line endoscopic treatment with the OTSC in acute non-variceal upper gastrointestinal bleeding and comparison with the Rockall cohort: the FLETRock study. Surg Endosc. 2018 Jan;32(1):307-314. doi: 10.1007/s00464-017-5678-7. Epub 2017 Jun 27.
PubMed 28656336Brandler J, Baruah A, Zeb M, Mehfooz A, Pophali P, Wong Kee Song L, AbuDayyeh B, Gostout C, Mara K, Dierkhising R, Buttar N. Efficacy of Over-the-Scope Clips in Management of High-Risk Gastrointestinal Bleeding. Clin Gastroenterol Hepatol. 2018 May;16(5):690-696.e1. doi: 10.1016/j.cgh.2017.07.020. Epub 2017 Jul 26.
PubMed 28756055Chandrasekar VT, Desai M, Aziz M, Patel HK, Gorrepati VS, Jegadeesan R, Rai T, Sathyamurthy A, Murino A, Hassan C, Repici A, Sharma P. Efficacy and safety of over-the-scope clips for gastrointestinal bleeding: a systematic review and meta-analysis. Endoscopy. 2019 Oct;51(10):941-949. doi: 10.1055/a-0994-4361. Epub 2019 Aug 30.
PubMed 31470449Jensen DM, Ohning GV, Kovacs TO, Ghassemi KA, Jutabha R, Dulai GS, Machicado GA. Doppler endoscopic probe as a guide to risk stratification and definitive hemostasis of peptic ulcer bleeding. Gastrointest Endosc. 2016 Jan;83(1):129-36. doi: 10.1016/j.gie.2015.07.012. Epub 2015 Aug 28.
PubMed 26318834
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial (RCT) of Standard Endoscopic Hemostasis Compared to OVESCO for Severe Non-variceal UGI Hemorrhage
- ClinicalTrials.gov ID
- NCT03065465
- Acronym / sponsor ID
- OVESCO
- Conditions
- Upper Gastrointestinal Hemorrhage
- Keywords
- Upper GI hemorrhage, Stigmata of recent hemorrhage, Ulcers, Dieulafoy's lesions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- CURE Digestive Diseases Research CenterUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, VA Greater Los Angeles Healthcare System
- Study start
- 15 Nov 2015
- Primary completion
- 24 Dec 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 28 Feb 2017 (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.
The primary specific aim is to perform a randomized controlled trial (RCT) to compare 30 day rebleed rates and other clinical outcomes of patients with severe, non-variceal upper GI hemorrhage (NVUGIH) - ulcers and Dieulafoy's lesions who are randomized as initial treatment with the new large over-the-scope-clip device for endoscopic hemostasis versus standard endoscopic hemostasis.
Detailed description
Upper GI Hemorrhage (UGIH) causes significant morbidity and mortality, although endoscopic hemostasis has revolutionized management of these patients. Despite standard endoscopic treatment and high dose proton pump infusions, 25% - 30% of high risk patients with UGIB from ulcers or other non-variceal UGI lesions (NVUGI) had recurrent bleeding in a recent RCT and cohort studies by our group. Potential risk factors for NVUGI rebleeding were large ulcers (≥ 15 mm), fibrotic bases, Dieulafoy's lesions, anastomotic ulcers, coagulopathies, cirrhosis, other severe co-morbidities and residual arterial blood flow under stigmata of recent hemorrhage (SRH) after endoscopic treatment. Such patients with rebleeding after standard endoscopic hemostasis usually required angiography (by interventional radiologists-IR) or surgery for definitive hemostasis. A new, large, FDA approved, over-the-scope hemoclipping device (OTSC® System OVESCO Endoscopy, Tübingen, Germany) can capture larger amounts of tissue and underlying arteries than standard hemoclips and potentially can improve endoscopic hemostasis of such bleeding lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard endoscopic treatment | Other | Other: Standard endoscopic treatmentFor those assigned to the standard endoscopy group, endoscopic hemostasis is performed using usual 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 SRH) of active bleeding or adherent clots (prior to snaring them off); coaptive coagulation with multipolar electrocautery (MPEC) probe and/or standard through the endoscope hemoclips along the course of the underlying artery as detected by DEP. Hemostasis is performed until active bleeding stops and/or the SRH is obliterated. Residual blood flow after visually guided hemostasis is recorded, but not used as a guide for additional hemostasis in this study. |
| Over-the-scope hemoclipping device | Experimental | Device: Over-the-scope hemoclipping deviceFor those assigned OTSC, prior to use of the OTSC in UGI lesions with active bleeding or adherent clots, dilute epinephrine (1: 20,000) is injected around the SRH in 1-2 cc aliquots and the clots are cold guillotined off, as previously described (2, 4, 17). As a brief additional description, after initial diagnosis and preparation of the lesion and SRH (as described for standard hemostasis), the therapeutic sized endoscope is removed and this or a diagnostic panendoscope will be affixed with the OTSC of appropriate size for the endoscope and the target lesion. The endoscope is re-introduced and passed to the bleeding site. The SRH is centered in the field of view and within the cap of the OTSC device. Using high suctioning and firm pressure to center the SRH, the lesion and SRH is captured into the cap and the OTSC is deployed by rotating the handle and thereby compressing the bleeding lesion and surrounding tissue with mechanical hemostasis. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent from the patient or a surrogate.
- Clinical evidence of severe UGIB.
- Presence of a benign appearing peptic ulcer, anastomotic ulcer, or Dieulafoy's lesion, with some SRH on endoscopy.
- Severe upper GI bleeding.
- Life expectancy of at least 30 days based on lack of severe or terminal comorbidity as judged by the generalist or subspecialist caring for the patient.
Key exclusion criteria (7 listed)
- Patients who are do-not-resuscitate (DNR) that is not reversible, uncooperative, refuse to participate, or are unable to give consent personally or through a legal surrogate.
- Active GI malignancy, under treatment but not in remission.
- Acute hypovolemic shock that is unresponsive to transfusion of 5 or more units of red blood cells (RBC's) or requires continuous intravenous vasopressor infusion for blood pressure support.
- ASA (American Society of Anesthesiology) class V or higher, moribund, or with a very poor prognosis and expected survival <30 days.
- Severe coagulopathy or thrombocytopenia despite attempted reversal with transfusion of blood products (e.g persistent International Normalized Ratio [INR] >2.0, platelet count <20,000, a Partial Thromboplastin Time [PTT] greater than 2x upper limit of normal).
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 |
|---|---|---|
| Over-the-scope hemoclipping deviceAlso: OTSC clipA endoscopic entrapment of tissue for control of bleeding or other applications. | Device | Over-the-scope hemoclipping device |
| Standard endoscopic treatmentStandard therapy includes injection of dilute epinephrine, thermal coagulation with multipolar electrocautery (MPEC) probe, and/or hemoclips. | Other | Standard endoscopic treatment |
Primary outcome
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 for all patients, ulcer patients only, and also patients with major stigmata of hemorrhage vs. lesser stigmata (oozing or flat spots).
2 secondary outcomes
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
Rates of surgery or IR, complications, and death
Time frame: Outcome measure will be assessed at 30 days after participants are enrolled
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Background: PubMed 22310222Laine L, Jensen DM. Management of patients with ulcer bleeding. Am J Gastroenterol. 2012 Mar;107(3):345-60; quiz 361. doi: 10.1038/ajg.2011.480. Epub 2012 Feb 7.
- Background: PubMed 27000531Camus M, Jensen DM, Kovacs TO, Jensen ME, Markovic D, Gornbein J. Independent risk factors of 30-day outcomes in 1264 patients with peptic ulcer bleeding in the USA: large ulcers do worse. Aliment Pharmacol Ther. 2016 May;43(10):1080-9. doi: 10.1111/apt.13591. Epub 2016 Mar 22.
- Background: PubMed 28167214Jensen DM, Kovacs TOG, Ohning GV, Ghassemi K, Machicado GA, Dulai GS, Sedarat A, Jutabha R, Gornbein J. Doppler Endoscopic Probe Monitoring of Blood Flow Improves Risk Stratification and Outcomes of Patients With Severe Nonvariceal Upper Gastrointestinal Hemorrhage. Gastroenterology. 2017 May;152(6):1310-1318.e1. doi: 10.1053/j.gastro.2017.01.042. Epub 2017 Feb 4.
- Background: PubMed 29803838Schmidt A, Golder S, Goetz M, Meining A, Lau J, von Delius S, Escher M, Hoffmann A, Wiest R, Messmann H, Kratt T, Walter B, Bettinger D, Caca K. Over-the-Scope Clips Are More Effective Than Standard Endoscopic Therapy for Patients With Recurrent Bleeding of Peptic Ulcers. Gastroenterology. 2018 Sep;155(3):674-686.e6. doi: 10.1053/j.gastro.2018.05.037. Epub 2018 May 24.
- Background: PubMed 23687412Nishiyama N, Mori H, Kobara H, Rafiq K, Fujihara S, Kobayashi M, Oryu M, Masaki T. Efficacy and safety of over-the-scope clip: including complications after endoscopic submucosal dissection. World J Gastroenterol. 2013 May 14;19(18):2752-60. doi: 10.3748/wjg.v19.i18.2752.
- Background: PubMed 23855514Monkemuller K, Peter S, Toshniwal J, Popa D, Zabielski M, Stahl RD, Ramesh J, Wilcox CM. Multipurpose use of the 'bear claw' (over-the-scope-clip system) to treat endoluminal gastrointestinal disorders. Dig Endosc. 2014 May;26(3):350-7. doi: 10.1111/den.12145. Epub 2013 Jul 16.
- Background: PubMed 17591492Kirschniak A, Kratt T, Stuker D, Braun A, Schurr MO, Konigsrainer A. A new endoscopic over-the-scope clip system for treatment of lesions and bleeding in the GI tract: first clinical experiences. Gastrointest Endosc. 2007 Jul;66(1):162-7. doi: 10.1016/j.gie.2007.01.034.
- Background: PubMed 23436101Manta R, Galloro G, Mangiavillano B, Conigliaro R, Pasquale L, Arezzo A, Masci E, Bassotti G, Frazzoni M. Over-the-scope clip (OTSC) represents an effective endoscopic treatment for acute GI bleeding after failure of conventional techniques. Surg Endosc. 2013 Sep;27(9):3162-4. doi: 10.1007/s00464-013-2871-1. Epub 2013 Feb 23.
- Background: PubMed 27895403Richter-Schrag HJ, Glatz T, Walker C, Fischer A, Thimme R. First-line endoscopic treatment with over-the-scope clips significantly improves the primary failure and rebleeding rates in high-risk gastrointestinal bleeding: A single-center experience with 100 cases. World J Gastroenterol. 2016 Nov 7;22(41):9162-9171. doi: 10.3748/wjg.v22.i41.9162.
- Background: PubMed 28924593Wedi E, von Renteln D, Gonzalez S, Tkachenko O, Jung C, Orkut S, Roth V, Tumay S, Hochberger J. Use of the over-the-scope-clip (OTSC) in non-variceal upper gastrointestinal bleeding in patients with severe cardiovascular comorbidities: a retrospective study. Endosc Int Open. 2017 Sep;5(9):E875-E882. doi: 10.1055/s-0043-105496. Epub 2017 Sep 12.
- Background: PubMed 31206010Golder S, Neuhas L, Freuer D, Probst A, Ebigbo A, Braun G, Brueckner J, Stueckle J, Meier A, Messmann H. Over-the-scope clip in peptic ulcer bleeding: clinical success in primary and secondary treatment and factors associated with treatment failure. Endosc Int Open. 2019 Jun;7(6):E846-E854. doi: 10.1055/a-0898-3357. Epub 2019 Jun 13.
- Background: PubMed 28656336Wedi E, Fischer A, Hochberger J, Jung C, Orkut S, Richter-Schrag HJ. Multicenter evaluation of first-line endoscopic treatment with the OTSC in acute non-variceal upper gastrointestinal bleeding and comparison with the Rockall cohort: the FLETRock study. Surg Endosc. 2018 Jan;32(1):307-314. doi: 10.1007/s00464-017-5678-7. Epub 2017 Jun 27.
- Individual participant dataSharing planned: No
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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.
Dennis M Jensen, MD principal investigator
University of California, Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Over-the-scope hemoclipping device and Standard endoscopic treatment in people with Upper Gastrointestinal Hemorrhage, run by CURE Digestive Diseases Research Center at 2 sites in United States.
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 5 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 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 Dennis M Jensen, MD (310-268-3569, djensen@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rebleeding rate of non-variceal focal UGI lesions (time frame: Outcome measure will be assessed at 30 days after participants are enrolled). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03065465, which also lists 17 linked publications.
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 27 Aug 2024; AzTrials last refreshed its copy on 7 Nov 2026.