NCT03113578

Brief Summary

This is an observational registry study collecting data on the clinical performance of the study device (DiLumen™ ) for its intended use. The primary objective is to evaluate functional outcomes of the DiLumen device in humans. The secondary objective is to evaluate safety characteristics of the DiLumen device.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2017

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

April 26, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2017

Completed
Last Updated

December 2, 2017

Status Verified

November 1, 2017

Enrollment Period

5 months

First QC Date

March 15, 2017

Last Update Submit

November 29, 2017

Conditions

Colon Polyp

Keywords

Balloon enteroscopycolonoscopypolyps

Outcome Measures

Primary Outcomes (1)

  • Performance

    Ability to reach cecum with the study device and scope \[Y or N\]

    Duration of procedure

Secondary Outcomes (2)

  • Incidence of Treatment Related Adverse Events

    Up to 3 months

  • Performance

    Duration of Procedure

Interventions

DiLumenDEVICE

The study device is placed over a compatible endoscope to facilitate endoscopic diagnosis and treatment of any large intestine pathology with the use of double balloons

Also known as: Endolumenal Interventional Platform

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients listed for routine surveillance colonoscopy for colorectal cancer.

You may qualify if:

  • Patients listed for routine surveillance colonoscopy for colorectal cancer and capable of giving informed consent

You may not qualify if:

  • No patients less than 18 years of age.
  • Any contraindication to routine surveillance colonoscopy
  • History of open or laparoscopic colorectal surgery
  • History of Inflammatory Bowel Disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Presbyterian Hospital

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Colonic PolypsPolyps

Condition Hierarchy (Ancestors)

Intestinal PolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine, Primary Investigator

Study Record Dates

First Submitted

March 15, 2017

First Posted

April 13, 2017

Study Start

April 26, 2017

Primary Completion

September 27, 2017

Study Completion

September 27, 2017

Last Updated

December 2, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)