Trials / Active Not Recruiting
Active Not RecruitingNCT03729453
Intra-operative Pancreatoscopy in Patients With IPMN
Intra-operative Pancreatoscopy in Patients With Intraductal Papillary Mucinous Neoplasm (IPMN)
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To demonstrate the added value of intraoperative pancreatoscopy in patients undergoing partial pancreatic resection for the treatment of Intraductal Papillary Mucinous Neoplasm (IPMN) as it pertains to detection of discontinuous (skip) lesions in the remnant pancreas; to generate a hypothesis for a subsequent randomized control trial.
Detailed description
The primary objective of this study is to demonstrate the added value of intraoperative pancreatoscopy in patients undergoing partial pancreatic resection for the treatment of Intraductal Papillary Mucinous Neoplasm (IPMN) as it pertains to detection of discontinuous (skip) lesions in the remnant pancreas. A secondary study objective is to generate a hypothesis for a subsequent randomized controlled trial comparing diagnostic accuracy of intra-operative pancreatoscopy and SpyBite™ with the diagnostic accuracy of intra-operative frozen section in patients undergoing resection
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SpyGlass | Visualization of main pancreatic duct with SpyGlass catheter. |
Timeline
- Start date
- 2019-03-20
- Primary completion
- 2022-08-11
- Completion
- 2027-05-01
- First posted
- 2018-11-02
- Last updated
- 2025-12-02
Locations
8 sites across 6 countries: United States, China, India, Japan, Netherlands, Sweden
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03729453. Inclusion in this directory is not an endorsement.