Cholangioscopy in Primary Sclerosing Cholangitis (PSC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03766035|
Recruitment Status : Recruiting
First Posted : December 5, 2018
Last Update Posted : September 23, 2019
|Condition or disease||Intervention/treatment|
|Primary Sclerosing Cholangitis (PSC)||Device: SpyGlass DS I - II|
|Study Type :||Observational|
|Estimated Enrollment :||105 participants|
|Official Title:||Cholangioscopy in Primary Sclerosing Cholangitis (PSC)|
|Actual Study Start Date :||December 6, 2018|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||August 2021|
Consented, enrolled PSC patients undergoing ERCP + SpyGlass
Patients with PSC who have been consented and enrolled in the study will undergo ERCP with the addition of SpyGlass as indicated by their treating physician.
Device: SpyGlass DS I - II
The SpyScope™ DS Access and Delivery Catheter (SpyScope™ DS Catheter) is a sterile, single-use endoscope that enables access and delivery of accessories to targeted pancreaticobiliary anatomy and displays live video when connected to a Spy Glass DS Digital Controller.
- Diagnostic Accuracy of POCS visualization for Early Detection of Cholangiocarcinoma [ Time Frame: 12 months ]Diagnostic accuracy of POCS visualization for cholangiocarcinoma evaluated clinically at 12 months after initial POCS procedure by clinical presentation.
- POCS-guided Biopsy for Early Detection of Cholangiocarcinoma [ Time Frame: 12 months ]Diagnostic accuracy for POCS-guided Biopsy for cholangiocarcinoma evaluated on pathology at 12 months after initial POCS procedure.
- Technical Success - Ability to advance the scope. [ Time Frame: Baseline ]Ability to advance the cholangioscope to the target stricture, ability to visualize the stricture and ability to obtain a tissue sample with Spy Bite where applicable.
- Rate of Adverse Events [ Time Frame: From index through study completion, an average of one year ]Serious adverse events from initial POCS procedure until end of follow-up.
- Proportion of patients identified for repeat procedure. [ Time Frame: During index procedure ]Proportion of patients identified for repeat procedure considering the addition of Spy Glass DS visualization and Spy Bite biopsy at Index compared to the proportion identified for repeat procedure without consideration of Spy Glass DS visualization and Spy Bite biopsy at Index.
- Correspondence of Biopsies [ Time Frame: From index through study completion, an average of one year ]Correlation between histopathology of Spy Bite biopsies collected during the initial POCS procedure and final diagnosis.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03766035
|Contact: Danielle Vannan, PhD||508-683-4139||Danielle.Vannan@bsci.com|
|Contact: Srey Yin||508-683-4162||Srey.Yin@bsci.com|
|United States, Utah|
|University of Utah Hospital and Clinic||Recruiting|
|Salt Lake City, Utah, United States, 84132|
|Contact: Linda Jo Taylor firstname.lastname@example.org|
|Principal Investigator: Douglas Adler, MD|
|Aspen Woods Clinic||Recruiting|
|Calgary, Alberta, Canada, T3H 0V5|
|Contact: Joni Tsougrianis email@example.com|
|Principal Investigator: Johannes Eksteen, MD, PhD|
|Sub-Investigator: Rachid Mohamed, MD|
|Sub-Investigator: Nauzer Forbes, MD|
|Academic Medical Center||Not yet recruiting|
|Amsterdam-Zuidoost, Netherlands, 1105 AZ|
|Principal Investigator: Cyriel Ponsioen, MD, PhD|
|Sub-Investigator: Jeanin van Hooft, MD|
|Rikshospitalet University Hospital||Not yet recruiting|
|Oslo, Norway, 0372|
|Contact: Siv Furholm firstname.lastname@example.org|
|Principal Investigator: Lars Aabakken, MD, PhD|
|Sub-Investigator: Vemund Paulsen, MD|
|Principal Investigator:||Johannes Eksteen, MD, PhD||Aspen Woods Clinic|
|Principal Investigator:||Douglas Adler, MD||University of Utah Hospital and Clinic|
|Principal Investigator:||Lars Aabakken, MD, PhD||Rikshospitalet Oslo|
|Principal Investigator:||Cyriel Ponsioen, MD, PhD||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|