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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EndoRotor Therapy | Experimental | Physicians will perform direct endoscopic necrosectomy using the EndoRotor in patients with walled off necrosis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EndoRotor Therapy | Device | To evaluate the EndoRotor's ability to safely remove non-viable/necrotic tissue for direct endoscopic necrosectomy in patients with walled off pancreatic necrosis. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 21 +/- 7 Days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 21 +/- 7 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marco Bruno, MD PhD | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Benjamin Tharian | Little Rock | Arkansas | 72205 | United States | ||
| Stanford University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34562471 | Derived | 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. |
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Enrollment Dates: November 2018 to August 2019
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
30 subjects were enrolled and treated. 1 subject did not complete follow-up (21 days following the final necrosectomy) as they expired; however, all data points were collected for analysis prior to this.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 21 +/- 7 Days |
|
Adverse Events were captured from Index Procedure through 21 day Follow-up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep Vein Thrombosis | Vascular disorders | Systematic Assessment | Moderate severity, not related to device, not related to procedure |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Moderate severity, not related to device, not related to procedure |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexis James Global Director of Clinical Affairs | Interscope, Inc. | 508-847-9478 | alexis.james@interscopemed.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 31, 2018 | Mar 2, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D019283 | Pancreatitis, Acute Necrotizing |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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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).
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| 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. | 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%. | 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. | 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. | 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. | 21 +/- 7 Days |
| Palo Alto |
| California |
| 94304 |
| United States |
| California Pacific Medical Center - Sutter Health | San Francisco | California | 94115 | United States |
| University of Chicago Department of Medicine | Chicago | Illinois | 60637 | United States |
| Rutgers Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08901 | United States |
| Arvin Trindade | Queens | New York | 11040 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| University of Frankfurt Medicine | Frankfurt | 60590 | Germany |
| Interdisciplinary Clinic for Endoscopy - TU Munich | München | 81675 | Germany |
| Erasmus Medical Center | Rotterdam | 3015 CE | Netherlands |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Cause of Pancreatitis | Count of Participants | Participants |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 21 +/- 7 Days |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Minutes | Completion of all necrosectomy procedures per patient |
|
|
|
| Secondary | 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%. | Posted | Mean | Standard Deviation | % Necrosis removed for all procedures | 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. |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Procedures | 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. |
|
|
|
| Secondary | 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. | Patients with outpatient visits were assigned 0.5 days conservatively | Posted | Mean | Standard Deviation | Days | At patient discharge from hospital |
|
|
|
| Secondary | 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. | All participants who had a completed SF-36v1 Questionnaire at both Baseline and the 21 Day Follow-up visit. | Posted | Mean | Standard Deviation | score on a scale | 21 +/- 7 Days |
|
|
|
|
| 1 |
| 30 |
| 9 |
| 30 |
| 11 |
| 30 |
|
| Hematemesis | Gastrointestinal disorders | Systematic Assessment | Moderate severity, not related to device, not related to procedure |
|
| Sepsis | Infections and infestations | Systematic Assessment | Moderate severity, not related to device, not related to procedure |
|
| Cholestasis | Hepatobiliary disorders | Systematic Assessment | Moderate severity, not related to device, not related to procedure |
|
| Gastrointestinal Bleed | Gastrointestinal disorders | Systematic Assessment | Event 1: Severe severity, not related to device, possible relationship to procedure Event 2: Moderate severity, not related to device, possible relationship to procedure |
|
| Pneumoperitoneum | Surgical and medical procedures | Systematic Assessment | Mild severity, not related to device, possible relationship to procedure |
|
| Multiple Organ Failure Syndrome | General disorders | Systematic Assessment | Severe severity, not related to device, not related to procedure. Patient later deceased |
|
| Pancreatitis | Hepatobiliary disorders | Systematic Assessment | Severe severity, not related to device, not related to procedure |
|
|
| Bacteremia | Infections and infestations | Systematic Assessment | Moderate severity, not related to device, not related to procedure |
|
| Colitis | Gastrointestinal disorders | Systematic Assessment | Mild severity, not related to device, not related to procedure |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment | Mild severity, no related to device, not related to procedure |
|
| Esophageal Candidiasis | Gastrointestinal disorders | Systematic Assessment | Moderate severity, not related to device, not related to procedure |
|
| Pyrexia | General disorders | Systematic Assessment | Moderate severity, not related to device, not related to procedure |
|
| Clostridium Difficile Infection | Infections and infestations | Systematic Assessment | Moderate severity, not related to device, not related to procedure |
|
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment | Mild severity, not related to device, not related to procedure |
|
| Insomnia | Nervous system disorders | Systematic Assessment | Mild severity, not related to device, not related to procedure |
|
| Device Dislocation (LAMS dislodgement) | Product Issues | Systematic Assessment | Mild severity, not related to device, definitely related to procedure |
|
| Anemia | Vascular disorders | Systematic Assessment | Moderate severity, not related to device possible relationship to procedure |
|
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.
| Role Limitations due to Emotional Problems |
|
| Energy / Fatigue |
|
| Emotional Well Being |
|
| Social Functioning |
|
| Pain |
|
| General Health |
|
Role Limitations due to Physical Health: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.
| Wilcoxon Signed Rank Test |
| 0.1152 |
p-values of <0.05 are considered significant |
| Mean Difference (Net) |
| 0 |
| 2-Sided |
| Superiority |
| Role Limitations due to Emotional Problems: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement. | Wilcoxon Signed Rank Test | 0.0552 | p-values of <0.05 are considered significant | Mean Difference (Net) | 0 | 2-Sided | Superiority |
| Energy/Fatigue: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement. | Wilcoxon Signed Rank Test | 0.039 | p-values of <0.05 are considered significant | Mean Difference (Net) | 0 | 2-Sided | Superiority |
| Emotional Well Being: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement. | Wilcoxon Signed Rank Test | 0.0223 | p-values of <0.05 are considered significant | Mean Difference (Net) | 0 | 2-Sided | Superiority |
| Social Functioning: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement. | Wilcoxon Signed Rank Test | 0.4664 | p-values of <0.05 are considered significant | Mean Difference (Net) | 0 | 2-Sided | Superiority |
| Pain: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement. | Wilcoxon Signed Rank Test | 0.0001 | p-values of <0.05 are considered significant | Mean Difference (Net) | 0 | 2-Sided | Superiority |
| General Health: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement. | Wilcoxon Signed Rank Test | 0.0639 | p-values of <0.05 are considered significant | Mean Difference (Net) | 0 | 2-Sided | Superiority |