Registry Evaluation of a Double Balloon Accessory Device

Multi-center Prospective Registry Study Utilizing a Double Balloon Accessory Device to Facilitate Endoscopic Polypectomy in Large Intestine.

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03942965

Enrollment

165

Registered

2019-05-08

Start date

2019-01-22

Completion date

2021-03-31

Last updated

2020-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenomatous Polyp of Colon

Brief summary

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.

Interventions

DEVICEDouble balloon accessory device

Double balloon accessory device is used during the endoscopic polypectomy procedure

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patients scheduled for endoscopic removal of suspected adenomatous benign polyps(s) 2. Patients capable of giving informed consent in English 3. No medical contraindication to endoscopic mucosal resection or endoscopic submucosal disection

Exclusion criteria

1. No patients less than 18 years of age. 2. Any contraindication to colonoscopy with due to subject's colon anatomy (i.e. stricture) 3. History of open or laparoscopic colorectal surgery 4. History of Inflammatory Bowel Disease

Design outcomes

Primary

Measure	Time frame	Description
Ability to perform the procedure safely and effectively with the study device.	Intraoperatively	Investigator answers yes or no

Secondary

Measure	Time frame	Description
Time to remove lesion after intervention begins	Intraoperatively	Time measurement in hours and minutes
Total time using study device during case	Intraoperatively	Time measurement in hours and minutes
Total case time	Intraoperatively	Time measurement in hours and minutes
Time to reach target lesion	Intraoperatively	Time measurement in hours and minutes
User feedback on device performance	Intraoperatively	Investigator rates the ease of use (easy, somewhat easy, somewhat difficult and difficult) of the device.
Number of Study Subjects with Treatment Related Adverse Events	Up to 30 days	No moderate to severe mucosal injury, perforations or bleeding related to the use of the device.
Total defect closure time	Intraoperatively	Time measurement in hours and minutes

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026