TransForm™ Occlusion Balloon Catheter Registry
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01949779|
Recruitment Status : Completed
First Posted : September 25, 2013
Last Update Posted : January 15, 2015
|Condition or disease||Intervention/treatment|
|Neurointerventional Procedure||Device: TransForm Occlusion Balloon Catheter|
- This is a prospective, single-arm, non-randomized, multi-center, observational registry.
- The expected duration for study enrollment is approximately 6 months-1 year.
- Study participation for each subject will be completed upon removal of the guide catheter post-procedure.
- Up to 140 subjects will be enrolled at up to 15 study sites. A given site will be allowed to enroll a maximum of 20 subjects.
- Enrollment in the registry occurs after a signed Informed Consent Form has been obtained, and the index procedure starts.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||81 participants|
|Target Follow-Up Duration:||1 Day|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
|TransForm OBC||Device: TransForm Occlusion Balloon Catheter|
- The ability of the TransForm™ Occlusion Balloon Catheter to reach the target site. [ Time Frame: Day 1 of the index procedure ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01949779
|United States, California|
|Desert Regional Medical Center|
|Palm Springs, California, United States, 92262|
|United States, Kentucky|
|Central Baptist Hospital|
|Lexington, Kentucky, United States, 40503|
|United States, Massachusetts|
|University of Massachusetts Medical School|
|Worcester, Massachusetts, United States, 01655|
|United States, Ohio|
|The Ohio State University Wexner Medical Center|
|Columbus, Ohio, United States, 43210|
|United States, West Virginia|
|West Virginia University|
|Morgantown, West Virginia, United States, 26505|
|United States, Wisconsin|
|Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Hospital Universitario Donostia|
|San Sebastian, Spain|