PROSPECTIVE, TRIAL EVALUATING THE SAFETY AND EFFECTIVENESS OF THE INTERSCOPE ENDOROTOR® RESECTION SYSTEM FOR DIRECT ENDOSCOPIC NECROSECTOMY OF WALLED OFF PANCREATIC NECROSIS
- Conditions
- encapsulated pancreatic necrosiswalled-off pancreatic necrosis10017998
- Registration Number
- NL-OMON47969
- Lead Sponsor
- Interscope Medical, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 5
1. Subjects who are >22; inclusive of males and females.
2. Patients with symptomatic pancreatic necrosis due to acute pancreatitis that have an indication
to undergo endoscopic necrosectomy after having undergone EUS-guided drainage
3. Imaging suggestive of greater than or equal to 30% necrotic material
4. Walled off pancreatic necrosis size *6 cm and *22cm
5. Subject can tolerate repeated endoscopic procedures
6. Subject capable of giving informed consent.
7. 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.
1. Subject unable to give informed consent.
2. Subject is unwilling to return for repeated endoscopies.
3. Documented Pseudoaneurysm > 1cm within the WOPN
4. Intervening gastric varices or unavoidable blood vessels within the access tract (visible using
endoscopy or endoscopic ultrasound).
5. Dual antiplatelet therapy or therapeutic anticoagulation that cannot be withheld for the procedure
6. 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).
7. 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.
8. Patient is known to be currently enrolled in another investigational trial that could interfere with the
endpoint analyses of this trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint of this study is the freedom from major complications. The<br /><br>safety endpoint will include an assessment of the safety of the EndoRotor when<br /><br>performing endoscopic necrosectomy. For the purpose of this study, the safety<br /><br>evaluation shall include complications associated with endoscopic necrosectomy<br /><br>through the 21 (+/-7) day follow-up period. Potential endoscopic<br /><br>complications include perforation and bleeding.</p><br>
- Secondary Outcome Measures
Name Time Method <p>* Successful clearance of necrosis in the collection treated during direct<br /><br>endoscopic necrosectomy where success is defined as at least 70% of the<br /><br>necrotic debris in the WOPN cavity is removed based on CT evaluation of<br /><br>the cavity at the 21 (+/-7) day follow up visit.<br /><br>* Assessment of total procedure time to achieve clearance of necrosis for all<br /><br>procedures<br /><br>* Assessment of adequacy of debridement<br /><br>* Assessment of total number of procedures to achieve clearance of necrosis<br /><br>* Assessment of length of hospital stay and utilization<br /><br>* SF-36 Questionnaire</p><br>