Multi-center Prospective Registry Study Utilizing a Double Balloon Accessory Device to Facilitate Endoscopic Polypectomy in Large Intestine.
Sponsor study identifier
observational
165
1 country
3
Study Start
January 22, 2019
Actual (reported)Primary Completion
December 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This study is collecting standard of care information pertaining to the use of the accessory device and patient outcomes when this double balloon accessory device is used during endoscopic procedures in the colon.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 22, 2019
Actual (reported)May 3, 2019
Actual (reported)May 8, 2019
Actual (reported)December 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Ability to perform the procedure safely and effectively with the study device.
Investigator answers yes or no
Intraoperatively
Time to reach target lesion
Intraoperatively
Time to remove lesion after intervention begins
Intraoperatively
Total time using study device during case
Intraoperatively
Total case time
Intraoperatively
Total defect closure time
Intraoperatively
Double balloon accessory device is used during the endoscopic polypectomy procedure
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Investigator's practice
University of Florida - Division of Gastroenterology, Hepatology and Nutrition
Gainesville, Florida, 32610, United States
Geisinger Health System
Danville, Pennsylvania, 17822, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Peter Draganov, MD
University of Florida
165 participants (actual enrollment reported by the registry).
First Submitted
May 3, 2019
First Posted
May 8, 2019
Study Start
January 22, 2019
Actual (reported)Screening for Colorectal Cancer in Average and High Risk Population
Contact the study team to confirm eligibility.
Primary Completion
December 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 11, 2020
Record last verified: 2020-12
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Source: ClinicalTrials.gov.
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