Trial Outcomes & Findings for EndoRotor DEN (Direct Endoscopic Necrosectomy)Trial (NCT NCT03694210)
NCT ID: NCT03694210
Last Updated: 2021-11-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
21 +/- 7 Days
Results posted on
2021-11-02
Participant Flow
Enrollment Dates: November 2018 to August 2019
Participant milestones
| Measure |
EndoRotor Therapy
Physicians will perform direct endoscopic necrosectomy using the EndoRotor in patients with walled off necrosis.
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.
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|---|---|
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Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
EndoRotor Therapy
Physicians will perform direct endoscopic necrosectomy using the EndoRotor in patients with walled off necrosis.
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.
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|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Screen Failure
|
7
|
Baseline Characteristics
EndoRotor DEN (Direct Endoscopic Necrosectomy)Trial
Baseline characteristics by cohort
| Measure |
EndoRotor Therapy
n=30 Participants
Physicians will perform direct endoscopic necrosectomy using the EndoRotor in patients with walled off necrosis.
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.
|
|---|---|
|
Age, Continuous
|
55.7 years
STANDARD_DEVIATION 15.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
2 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
5 participants
n=5 Participants
|
|
Cause of Pancreatitis
Gallstone/biliary
|
18 Participants
n=5 Participants
|
|
Cause of Pancreatitis
Alcohol
|
5 Participants
n=5 Participants
|
|
Cause of Pancreatitis
Unknown Cause
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 21 +/- 7 DaysThe 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.
Outcome measures
| Measure |
EndoRotor Therapy
n=30 Participants
Physicians will perform direct endoscopic necrosectomy using the EndoRotor in patients with walled off necrosis.
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.
|
21 Day Post Necrosectomy SF-36v1 Score
21 Day Post Necrosectomy SF-36v1 results for 8 domains
|
|---|---|---|
|
Safety: Number of Participants With Device Related Complications
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 21 +/- 7 DaysSuccessful 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.
Outcome measures
| Measure |
EndoRotor Therapy
n=30 Participants
Physicians will perform direct endoscopic necrosectomy using the EndoRotor in patients with walled off necrosis.
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.
|
21 Day Post Necrosectomy SF-36v1 Score
21 Day Post Necrosectomy SF-36v1 results for 8 domains
|
|---|---|---|
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Effectiveness: Number of Participants With at Least 70% of Necrotic Debris Removed
|
29 Participants
|
—
|
SECONDARY outcome
Timeframe: Completion of all necrosectomy procedures per patientAssessment 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.
Outcome measures
| Measure |
EndoRotor Therapy
n=30 Participants
Physicians will perform direct endoscopic necrosectomy using the EndoRotor in patients with walled off necrosis.
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.
|
21 Day Post Necrosectomy SF-36v1 Score
21 Day Post Necrosectomy SF-36v1 results for 8 domains
|
|---|---|---|
|
Mean Total Procedure Time to Achieve at Least 70% Reduction in Necrosis
Total Procedure Time
|
117 Minutes
Standard Deviation 50
|
—
|
|
Mean Total Procedure Time to Achieve at Least 70% Reduction in Necrosis
EndoRotor Time
|
71 Minutes
Standard Deviation 37
|
—
|
SECONDARY outcome
Timeframe: 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.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%.
Outcome measures
| Measure |
EndoRotor Therapy
n=30 Participants
Physicians will perform direct endoscopic necrosectomy using the EndoRotor in patients with walled off necrosis.
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.
|
21 Day Post Necrosectomy SF-36v1 Score
21 Day Post Necrosectomy SF-36v1 results for 8 domains
|
|---|---|---|
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Adequacy of Procedural Debridement: Mean Percent Necrotic Material Removed From the WOPN Cavity Per Procedure.
|
60 % Necrosis removed for all procedures
Standard Deviation 33
|
—
|
SECONDARY outcome
Timeframe: 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.The total number of necrosectomy procedures required per participant to achieve at least 70% reduction in necrosis from the WOPN will be assessed.
Outcome measures
| Measure |
EndoRotor Therapy
n=30 Participants
Physicians will perform direct endoscopic necrosectomy using the EndoRotor in patients with walled off necrosis.
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.
|
21 Day Post Necrosectomy SF-36v1 Score
21 Day Post Necrosectomy SF-36v1 results for 8 domains
|
|---|---|---|
|
Mean Number of Necrosectomy Procedures Required Per Participant to Achieve at Least 70% Reduction in Necrosis.
|
2 Procedures
Standard Deviation 2
|
—
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SECONDARY outcome
Timeframe: At patient discharge from hospitalPopulation: Patients with outpatient visits were assigned 0.5 days conservatively
The total length of hospital stay per participant measured in days, from the date of the index necrosectomy procedure to the date of discharge.
Outcome measures
| Measure |
EndoRotor Therapy
n=30 Participants
Physicians will perform direct endoscopic necrosectomy using the EndoRotor in patients with walled off necrosis.
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.
|
21 Day Post Necrosectomy SF-36v1 Score
21 Day Post Necrosectomy SF-36v1 results for 8 domains
|
|---|---|---|
|
Mean Length of Hospital Stay Per Participant
|
18 Days
Standard Deviation 25
|
—
|
SECONDARY outcome
Timeframe: 21 +/- 7 DaysPopulation: All participants who had a completed SF-36v1 Questionnaire at both Baseline and the 21 Day Follow-up visit.
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.
Outcome measures
| Measure |
EndoRotor Therapy
n=24 Participants
Physicians will perform direct endoscopic necrosectomy using the EndoRotor in patients with walled off necrosis.
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.
|
21 Day Post Necrosectomy SF-36v1 Score
n=24 Participants
21 Day Post Necrosectomy SF-36v1 results for 8 domains
|
|---|---|---|
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Quality of Life - Short Form 36-Item Health Survey Version 1 (SF-36v1), Physical & Emotional Composite Score
Physical Functioning
|
36.0 score on a scale
Standard Deviation 30.8
|
57.3 score on a scale
Standard Deviation 30.8
|
|
Quality of Life - Short Form 36-Item Health Survey Version 1 (SF-36v1), Physical & Emotional Composite Score
Role Limitations due to Physical Health
|
11.4 score on a scale
Standard Deviation 28.5
|
25.0 score on a scale
Standard Deviation 37.6
|
|
Quality of Life - Short Form 36-Item Health Survey Version 1 (SF-36v1), Physical & Emotional Composite Score
Role Limitations due to Emotional Problems
|
27.8 score on a scale
Standard Deviation 41.3
|
51.4 score on a scale
Standard Deviation 48.1
|
|
Quality of Life - Short Form 36-Item Health Survey Version 1 (SF-36v1), Physical & Emotional Composite Score
Energy / Fatigue
|
27.9 score on a scale
Standard Deviation 22.0
|
36.7 score on a scale
Standard Deviation 23.2
|
|
Quality of Life - Short Form 36-Item Health Survey Version 1 (SF-36v1), Physical & Emotional Composite Score
Emotional Well Being
|
60.7 score on a scale
Standard Deviation 19.7
|
68.3 score on a scale
Standard Deviation 18.9
|
|
Quality of Life - Short Form 36-Item Health Survey Version 1 (SF-36v1), Physical & Emotional Composite Score
Social Functioning
|
51.6 score on a scale
Standard Deviation 32.6
|
56.3 score on a scale
Standard Deviation 26.6
|
|
Quality of Life - Short Form 36-Item Health Survey Version 1 (SF-36v1), Physical & Emotional Composite Score
Pain
|
31.4 score on a scale
Standard Deviation 28.4
|
56.0 score on a scale
Standard Deviation 30.1
|
|
Quality of Life - Short Form 36-Item Health Survey Version 1 (SF-36v1), Physical & Emotional Composite Score
General Health
|
47.8 score on a scale
Standard Deviation 15.9
|
53.8 score on a scale
Standard Deviation 15.3
|
Adverse Events
EndoRotor Therapy
Serious events: 9 serious events
Other events: 11 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
EndoRotor Therapy
n=30 participants at risk
Physicians will perform direct endoscopic necrosectomy using the EndoRotor in patients with walled off necrosis.
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.
|
|---|---|
|
Vascular disorders
Deep Vein Thrombosis
|
3.3%
1/30 • Number of events 1 • Adverse Events were captured from Index Procedure through 21 day Follow-up
|
|
Gastrointestinal disorders
Hematemesis
|
3.3%
1/30 • Number of events 1 • Adverse Events were captured from Index Procedure through 21 day Follow-up
|
|
Infections and infestations
Sepsis
|
3.3%
1/30 • Number of events 1 • Adverse Events were captured from Index Procedure through 21 day Follow-up
|
|
Hepatobiliary disorders
Cholestasis
|
3.3%
1/30 • Number of events 1 • Adverse Events were captured from Index Procedure through 21 day Follow-up
|
|
Gastrointestinal disorders
Gastrointestinal Bleed
|
6.7%
2/30 • Number of events 2 • Adverse Events were captured from Index Procedure through 21 day Follow-up
|
|
Surgical and medical procedures
Pneumoperitoneum
|
3.3%
1/30 • Number of events 1 • Adverse Events were captured from Index Procedure through 21 day Follow-up
|
|
General disorders
Multiple Organ Failure Syndrome
|
3.3%
1/30 • Number of events 1 • Adverse Events were captured from Index Procedure through 21 day Follow-up
|
|
Hepatobiliary disorders
Pancreatitis
|
3.3%
1/30 • Number of events 1 • Adverse Events were captured from Index Procedure through 21 day Follow-up
|
Other adverse events
| Measure |
EndoRotor Therapy
n=30 participants at risk
Physicians will perform direct endoscopic necrosectomy using the EndoRotor in patients with walled off necrosis.
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.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
3.3%
1/30 • Number of events 1 • Adverse Events were captured from Index Procedure through 21 day Follow-up
|
|
Infections and infestations
Bacteremia
|
3.3%
1/30 • Number of events 1 • Adverse Events were captured from Index Procedure through 21 day Follow-up
|
|
Gastrointestinal disorders
Colitis
|
3.3%
1/30 • Number of events 1 • Adverse Events were captured from Index Procedure through 21 day Follow-up
|
|
Gastrointestinal disorders
Diarrhea
|
3.3%
1/30 • Number of events 1 • Adverse Events were captured from Index Procedure through 21 day Follow-up
|
|
Gastrointestinal disorders
Esophageal Candidiasis
|
3.3%
1/30 • Number of events 1 • Adverse Events were captured from Index Procedure through 21 day Follow-up
|
|
General disorders
Pyrexia
|
3.3%
1/30 • Number of events 1 • Adverse Events were captured from Index Procedure through 21 day Follow-up
|
|
Infections and infestations
Clostridium Difficile Infection
|
3.3%
1/30 • Number of events 1 • Adverse Events were captured from Index Procedure through 21 day Follow-up
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.3%
1/30 • Number of events 1 • Adverse Events were captured from Index Procedure through 21 day Follow-up
|
|
Nervous system disorders
Insomnia
|
3.3%
1/30 • Number of events 1 • Adverse Events were captured from Index Procedure through 21 day Follow-up
|
|
Product Issues
Device Dislocation (LAMS dislodgement)
|
3.3%
1/30 • Number of events 1 • Adverse Events were captured from Index Procedure through 21 day Follow-up
|
|
Vascular disorders
Anemia
|
3.3%
1/30 • Number of events 1 • Adverse Events were captured from Index Procedure through 21 day Follow-up
|
Additional Information
Alexis James Global Director of Clinical Affairs
Interscope, Inc.
Phone: 508-847-9478
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee At least sixty days before publication submission PI shall submit to Sponsor for review and comment. PI will consider comments, but is not obligated to incorporate suggestions. Publication shall acknowledge Sponsor contributions as appropriate. Investigator agrees that first publication of results shall be a joint, multicenter publication, with the investigators and the institutions from all appropriate sites contributing data, analyses and comments.
- Publication restrictions are in place
Restriction type: OTHER