Acute Pancreatic NecrosisNCT03694210
EndoRotor DEN (Direct Endoscopic Necrosectomy)Trial
A study testing EndoRotor Therapy in people with Acute Pancreatic Necrosis and Acute Pancreatitis, run by Interscope, Inc. at 10 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Acute Pancreatic Necrosis, Acute Pancreatitis, Necrotizing Pancreatitis
- What is being tested?
- EndoRotor Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 15 Nov 2018to 22 Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
United States7 sites
University of Chicago Department of Medicine
Chicago, Illinois, 60637
Benjamin Tharian
Little Rock, Arkansas, 72205
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
Stanford University Medical Center
Palo Alto, California, 94304
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Arvin Trindade
Queens, New York, 11040
California Pacific Medical Center - Sutter Health
San Francisco, California, 94115
Germany2 sites
University of Frankfurt Medicine
Frankfurt, 60590
Interdisciplinary Clinic for Endoscopy - TU Munich
München, 81675
About this study
Official title: Prospective, Trial Evaluating the Safety and Effectiveness of the Interscope Endorotor® System for Direct Endoscopic Necrosectomy of Walled Off Pancreatic Necrosis
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).
Read the detailed 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). 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.
- Being tested
- EndoRotor Therapy
- Keywords
- Direct Endoscopic Necrosectomy, Walled Off Necrosis, Walled Off Pancreatic Necrosis
- Medical subject headings
- Pancreatitis, Pancreatitis, Acute Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoRotor TherapyDevice
To evaluate the EndoRotor's ability to safely remove non-viable/necrotic tissue for direct endoscopic necrosectomy in patients with walled off pancreatic necrosis.
| Study group | Role | What they receive |
|---|---|---|
| EndoRotor Therapy | Experimental | Physicians will perform direct endoscopic necrosectomy using the EndoRotor in patients with walled off necrosis. Receives: Device: EndoRotor Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Number of Participants With Device Related Complications
The primary endpoint of this study is the freedom from major device related 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.
Measured: 21 +/- 7 Days
Secondary outcomes (6)
Effectiveness: Number of Participants With at Least 70% of Necrotic Debris Removed
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 follow up visit.
Measured: 21 +/- 7 Days
Mean Total Procedure Time to Achieve at Least 70% Reduction in Necrosis
Assessment of total procedure time to achieve clearance of necrosis for all procedures.
Total procedure time is measured from scope-in to scope-out. EndoRotor time is measured from the start of EndoRotor use to the end of EndoRotor use.
Measured: Completion of all necrosectomy procedures per patient
Adequacy of Procedural Debridement: Mean Percent Necrotic Material Removed From the WOPN Cavity Per Procedure.
At the completion of each necrosectomy procedure the Investigator will visually inspect the WOPN cavity endoscopically and estimate the percent of necrosis that was removed from the cavity using EndoRotor. For each procedure, the initial amount of necrosis in the WOPN cavity is considered 100%.
Measured: This outcome was assessed at the completion each necrosectomy procedure per participant. At the completion of all necrosectomy procedures for all participants, an overall mean percent necrotic material removed from the WOPN per procedure was calculated.
Mean Number of Necrosectomy Procedures Required Per Participant to Achieve at Least 70% Reduction in Necrosis.
The total number of necrosectomy procedures required per participant to achieve at least 70% reduction in necrosis from the WOPN will be assessed.
Measured: This outcome was assessed at completion of all necrosectomy procedures per participant. After completion of all necrosectomy procedures in all participants the overall mean number of procedures to achieve at least 70% reduction in necrosis was calculated.
Mean Length of Hospital Stay Per Participant
The total length of hospital stay per participant measured in days, from the date of the index necrosectomy procedure to the date of discharge.
Measured: At patient discharge from hospital
Quality of Life - Short Form 36-Item Health Survey Version 1 (SF-36v1), Physical & Emotional Composite Score
The SF-36v1 questionnaire measures functional health and well-being from a patient's point of view. The questionnaire assess eight health domains including: Physical Functioning, Role Limitations due to Physical Health, Role Limitations due to Emotional Problems, Energy/Fatigue, Emotional Well Being, Social Functioning, Pain, and General Health.
Participants were asked to complete the questionnaire at the Baseline Visit and then again at the 21 Day Post Necrosectomy Follow-up Visit. The results of the questionnaire from the 21 Day Post Necrosectomy Follow-up Visit were then compared to those of Baseline for improvement.
Numeric scores for each health domain are reported on a scale of 0-100 with improvement demonstrated by a higher score than baseline. Statistically significant improvement is denoted by differences in Baseline and 21 Day Follow-up Visit scores that have a p-value < 0.05.
Measured: 21 +/- 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start15 Nov 2018
- Primary completion22 Aug 2019
- Study completion22 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Pancreatic NecrosisStudies 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
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Interscope, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marco Bruno, MD PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03694210
- Sponsor's protocol ID
- CLIN-0047
- Status last verified
- Oct 2021
- First submitted
- 26 Sep 2018
- Last updated
- 2 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Stassen PMC, de Jonge PJF, Bruno MJ, Koch AD, Trindade AJ, Benias PC, Sejpal DV, Siddiqui UD, Chapman CG, Villa E, Tharian B, Inamdar S, Hwang JH, Barakat MT, Andalib I, Gaidhane M, Sarkar A, Shahid H, Tyberg A, Binmoeller K, Watson RR, Nett A, Schlag C, Abdelhafez M, Friedrich-Rust M, Schlachterman A, Chiang AL, Loren D, Kowalski T, Kahaleh M. Safety and efficacy of a novel resection system for direct endoscopic necrosectomy of walled-off pancreas necrosis: a prospective, international, multicenter trial. Gastrointest Endosc. 2022 Mar;95(3):471-479. doi: 10.1016/j.gie.2021.09.025. Epub 2021 Sep 22.
PubMed 34562471
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Trial Evaluating the Safety and Effectiveness of the Interscope Endorotor® System for Direct Endoscopic Necrosectomy of Walled Off Pancreatic Necrosis
- ClinicalTrials.gov ID
- NCT03694210
- Acronym / sponsor ID
- CLIN-0047
- Keywords
- Direct Endoscopic Necrosectomy, Walled Off Necrosis, Walled Off Pancreatic Necrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Interscope, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 22 Aug 2019 (actual)
- Study completion
- 22 Aug 2019 (actual)
- First posted
- 3 Oct 2018 (actual)
- Results
- Posted 2 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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). 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| EndoRotor Therapy | Experimental | Device: EndoRotor TherapyPhysicians will perform direct endoscopic necrosectomy using the EndoRotor in patients with walled off necrosis. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| EndoRotor TherapyTo evaluate the EndoRotor's ability to safely remove non-viable/necrotic tissue for direct endoscopic necrosectomy in patients with walled off pancreatic necrosis. | Device | EndoRotor Therapy |
Primary outcome
Safety: Number of Participants With Device Related Complications
Time frame: 21 +/- 7 Days
The primary endpoint of this study is the freedom from major device related 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.
6 secondary outcomes
Effectiveness: Number of Participants With at Least 70% of Necrotic Debris Removed
Time frame: 21 +/- 7 Days
Mean Total Procedure Time to Achieve at Least 70% Reduction in Necrosis
Time frame: Completion of all necrosectomy procedures per patient
Adequacy of Procedural Debridement: Mean Percent Necrotic Material Removed From the WOPN Cavity Per Procedure.
Time frame: This outcome was assessed at the completion each necrosectomy procedure per participant. At the completion of all necrosectomy procedures for all participants, an overall mean percent necrotic material removed from the WOPN per procedure was calculated.
Mean Number of Necrosectomy Procedures Required Per Participant to Achieve at Least 70% Reduction in Necrosis.
Time frame: This outcome was assessed at completion of all necrosectomy procedures per participant. After completion of all necrosectomy procedures in all participants the overall mean number of procedures to achieve at least 70% reduction in necrosis was calculated.
Mean Length of Hospital Stay Per Participant
Time frame: At patient discharge from hospital
Quality of Life - Short Form 36-Item Health Survey Version 1 (SF-36v1), Physical & Emotional Composite Score
Time frame: 21 +/- 7 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34562471Stassen PMC, de Jonge PJF, Bruno MJ, Koch AD, Trindade AJ, Benias PC, Sejpal DV, Siddiqui UD, Chapman CG, Villa E, Tharian B, Inamdar S, Hwang JH, Barakat MT, Andalib I, Gaidhane M, Sarkar A, Shahid H, Tyberg A, Binmoeller K, Watson RR, Nett A, Schlag C, Abdelhafez M, Friedrich-Rust M, Schlachterman A, Chiang AL, Loren D, Kowalski T, Kahaleh M. Safety and efficacy of a novel resection system for direct endoscopic necrosectomy of walled-off pancreas necrosis: a prospective, international, multicenter trial. Gastrointest Endosc. 2022 Mar;95(3):471-479. doi: 10.1016/j.gie.2021.09.025. Epub 2021 Sep 22.
- 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.
Marco Bruno, MD PhD principal investigator
Erasmus Medical Center
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EndoRotor Therapy in people with Acute Pancreatic Necrosis and Acute Pancreatitis, run by Interscope, Inc. at 10 sites in 3 countries.
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 7 inclusion and 8 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: finished, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Germany, Netherlands. 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?
Yes. Results are posted in the registry (first posted 2 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Number of Participants With Device Related Complications (time frame: 21 +/- 7 Days). 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 NCT03694210, which also lists 1 linked publication.
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 2 Nov 2021.