Registry Evaluation of a Double Balloon Accessory Device | NCT03942965

Studies
Registry Evaluation of a Double Balloon Accessory Device

NCT03942965

Sponsor

Lumendi, LLC

Status

Unknown status

Last Update Posted

Dec 11, 2020Actual

Enrollment

165Actual

Phase

Not provided

Conditions

Adenomatous Polyp of Colon

Interventions

Double balloon accessory device

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 22, 2019Actual

Primary Completion Date

Dec 31, 2020Estimated

Completion Date

Mar 31, 2021Estimated

First Submitted Date

May 3, 2019

First Submission Date that Met QC Criteria

May 7, 2019

First Posted Date

May 8, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2020

Last Update Posted Date

Dec 11, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

30 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

165Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Double balloon accessory device	Device	Double balloon accessory device is used during the endoscopic polypectomy procedure		DiLumen

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Time to reach target lesion	Time measurement in hours and minutes	Intraoperatively
Time to remove lesion after intervention begins	Time measurement in hours and minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Investigator's practice

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Draganov, MD	University of Florida	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Florida - Division of Gastroenterology, Hepatology and Nutrition		Gainesville	Florida	32610	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided