NCT02947997

Brief Summary

The purpose of this study is to test feasibility of a redesigned tethered capsule catheter that contains an integrated micro-motor. Investigators will be testing imaging of this new technology in healthy volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2015

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

Study Start

First participant enrolled

September 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2016

Completed
7 months until next milestone

First Posted

Study publicly available on registry

October 28, 2016

Completed
3 years until next milestone

Results Posted

Study results publicly available

November 14, 2019

Completed
Last Updated

January 17, 2023

Status Verified

January 1, 2023

Enrollment Period

2 months

First QC Date

April 14, 2016

Results QC Date

July 20, 2018

Last Update Submit

January 12, 2023

Conditions

Healthy

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Number of Participants For Whom Good Quality Images Were Recorded After Swallowing The OFDI Capsule

    An investigator to assess the quality of the recorded images obtained with each exam after imaging has been completed

    Approximate 20 minute visit (5 min image acquisition)

Study Arms (1)

OFDI capsule imaging

Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI imaging system.

Device: OFDI capsule

Interventions

OFDI capsuleDEVICE

Imaging of esophagus using OFDI capsule and system

OFDI capsule imaging

Eligibility Criteria

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

Healthy Volunteers

You may qualify if:

  • Subjects must be over the age of 18
  • Subjects must be able to give informed consent
  • Subjects must have no solid food for 4 hours prior to the procedure, and only clear liquids for 2 hours prior to the procedure.

You may not qualify if:

  • Subjects with the inability to swallow pills and capsules.
  • Esophageal fistula and/or esophageal strictures with a stricture diameter that is smaller than the diameter of the capsule.
  • Subjects who have a bleeding disorder and are currently on anti-coagulants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Results Point of Contact

Title
Gary Tearney, MD
Organization
Massachusetts General Hospital
gtearney@partners.org
617-724-2979

Study Officials

  • Guillermo Tearney, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 14, 2016

First Posted

October 28, 2016

Study Start

September 1, 2015

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

January 17, 2023

Results First Posted

November 14, 2019

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)