Trial record 2 of 4 for:
endorotor
EndoRotor DEN (Direct Endoscopic Necrosectomy)Trial
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03694210 |
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Recruitment Status :
Completed
First Posted : October 3, 2018
Last Update Posted : September 4, 2019
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Sponsor:
Interscope, Inc.
Information provided by (Responsible Party):
Interscope, Inc.
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Brief Summary:
A prospective, single arm, open label, multi-center, trial to evaluate the safety and effectiveness of the Interscope EndoRotor® Resection System in subjects requiring direct endoscopic necrosectomy (DEN) with walled off pancreatic necrosis (WOPN).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Pancreatic Necrosis Acute Pancreatitis Necrotizing Pancreatitis | Device: EndoRotor Therapy | Not Applicable |
A prospective, single arm, open label, multi-center, trial to evaluate the safety and effectiveness of the Interscope EndoRotor® Resection System in subjects requiring direct endoscopic necrosectomy with walled off pancreatic necrosis (WOPN). Total enrollment 30 subjects with at least 15 enrolled in the US.
Subjects will be debrided with the EndoRotor either at the time of stent placement or post placement at Investigator's discretion with a maximum of 4 EndoRotor procedures. A minimum of 2 days is required between each EndoRotor procedure and all procedures need to be completed within a 14 (+7/-0) day period. Follow up is completed 21 (+/- 7) days after last EndoRotor debridement procedure.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 30 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | A prospective, single arm, open label, multi-center, trial to evaluate the safety and effectiveness of the Interscope EndoRotor® Resection System in subjects requiring direct endoscopic necrosectomy with walled off pancreatic necrosis (WOPN). |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Prospective, Trial Evaluating the Safety and Effectiveness of the Interscope Endorotor® System for Direct Endoscopic Necrosectomy of Walled Off Pancreatic Necrosis |
| Actual Study Start Date : | November 15, 2018 |
| Actual Primary Completion Date : | August 22, 2019 |
| Actual Study Completion Date : | August 22, 2019 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Hereditary pancreatitis
MedlinePlus related topics:
Endoscopy
| Arm | Intervention/treatment |
|---|---|
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Experimental: EndoRotor Therapy
Physicians will perform direct endoscopic necrosectomy using the EndoRotor in patients with walled off necrosis.
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Device: EndoRotor Therapy
To evaluate the EndoRotor's ability to safely remove non-viable/necrotic tissue for direct endoscopic necrosectomy in patients with walled off pancreatic necrosis. |
Primary Outcome Measures :
- Safety: Rate of major complications [ Time Frame: 21 +/- 7 Days ]The primary endpoint of this study is the freedom from major complications. The safety endpoint will include an assessment of the safety of the EndoRotor when performing endoscopic necrosectomy. For the purpose of this study, the safety evaluation shall include complications associated with endoscopic necrosectomy through the 21 (+/-7) day follow-up period. Potential endoscopic complications include perforation and bleeding.
Secondary Outcome Measures :
- Effectiveness: Percentage of necrosis removed measured by CT Scan [ Time Frame: 21 +/- 7 Days ]Successful clearance of necrosis in the collection being treated during direct endoscopic necrosectomy where success is defined as at least 70% of the necrotic debris in the collection being treated is removed based on CT evaluation of the cavity at the 21 (+/-7) day day follow up visit.
- Procedure Time: Record each procedure time [ Time Frame: 14 Days ]Assessment of total procedure time to achieve clearance of necrosis for all procedures.
- Adequacy of Procedural Debridement: Visual estimation of percent removal of necrosis from the site based on endoscopic view [ Time Frame: 14 Days ]At conclusion of the procedure, the percent removal of the total necrosis present will be visually estimated by the Investigator as a measure of removal adequacy with the EndoRotor
- Number of Procedures: Record total number of procedures to achieve clearance [ Time Frame: 14 Days ]Assessment of total number of procedures to achieve clearance of necrosis.
- Hospital Resource Utilization: Total length of hospital stay [ Time Frame: 21 +/- 7 Days ]The total length of hospital stay measured from the first use of the EndoRotor to study exit at the 21 day follow up visit will be used to determine potential economic advantages of the EndoRotor procedure.
- Quality of Life - SF-36v2 Health Survey, Physical Composite Score [ Time Frame: 21 +/- 7 Days ]Evaluation of Physical Component Score for improved quality of life. Score will be reported on a scale of 0-100 with improvement demonstrated by a higher score above the mean value of 50
- Quality of Life - SF-36v2 Health Survey, Mental Composite Score [ Time Frame: 21 +/- 7 Days ]Evaluation of Mental Component Score for improved quality of life. Score will be reported on a scale of 0-100 with improvement demonstrated by a higher score above the mean value of 50
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| Ages Eligible for Study: | 22 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects who are >22; inclusive of males and females.
- Patients with symptomatic pancreatic necrosis due to acute pancreatitis that have an indication to undergo endoscopic necrosectomy after having undergone EUS-guided drainage
- Imaging suggestive of greater than or equal to 30% necrotic material
- Walled off pancreatic necrosis size ≥6 cm and ≤22cm
- Subject can tolerate repeated endoscopic procedures
- Subject capable of giving informed consent.
- Subjects with the ability to understand the requirements of the study, who have provided written informed consent, and who are willing and able to return for the required follow-up assessments through 21 (+/- 7) days, as indicated.
Exclusion Criteria:
- Subject unable to give informed consent.
- Subject is unwilling to return for repeated endoscopies.
- Documented Pseudoaneurysm > 1cm within the WOPN
- Intervening gastric varices or unavoidable blood vessels within the access tract (visible using endoscopy or endoscopic ultrasound).
- Dual antiplatelet therapy or therapeutic anticoagulation that cannot be withheld for the procedure
- Any condition that in the opinion of the investigator would create an unsafe clinical situation that would not allow the patient to safely undergo an endoscopic procedure (lack of medical clearance).
- Pregnant or lactating women or women of childbearing potential who do not employ a reliable method of contraception as judged by the Investigator, and/or are not willing to use reliable contraception for the duration of study participation.
- Patient is known to be currently enrolled in another investigational trial that could interfere with the endpoint analyses of this trial.
Information from the National Library of Medicine
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): NCT03694210
Locations
| United States, Arkansas | |
| Benjamin Tharian | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Stanford University Medical Center | |
| Palo Alto, California, United States, 94304 | |
| California Pacific Medical Center - Sutter Health | |
| San Francisco, California, United States, 94115 | |
| United States, Illinois | |
| University of Chicago Department of Medicine | |
| Chicago, Illinois, United States, 60637 | |
| United States, New Jersey | |
| Rutgers Robert Wood Johnson Medical School | |
| New Brunswick, New Jersey, United States, 08901 | |
| United States, New York | |
| Arvin Trindade | |
| Queens, New York, United States, 11040 | |
| United States, Pennsylvania | |
| Thomas Jefferson University | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Germany | |
| University of Frankfurt Medicine | |
| Frankfurt, Germany, 60590 | |
| Interdisciplinary Clinic for Endoscopy - TU Munich | |
| München, Germany, 81675 | |
| Netherlands | |
| Erasmus Medical Center | |
| Rotterdam, Netherlands, 3015 CE | |
Sponsors and Collaborators
Interscope, Inc.
Investigators
| Principal Investigator: | Marco Bruno, MD PhD | Erasmus Medical Center |
| Responsible Party: | Interscope, Inc. |
| ClinicalTrials.gov Identifier: | NCT03694210 |
| Other Study ID Numbers: |
CLIN-0047 |
| First Posted: | October 3, 2018 Key Record Dates |
| Last Update Posted: | September 4, 2019 |
| Last Verified: | April 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
Keywords provided by Interscope, Inc.:
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Direct Endoscopic Necrosectomy Walled Off Necrosis Walled Off Pancreatic Necrosis |
Additional relevant MeSH terms:
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Pancreatitis Pancreatitis, Acute Necrotizing Necrosis |
Pancreatic Diseases Digestive System Diseases Pathologic Processes |