Pilot Study for Imaging of the Esophagus Using a Tethered Capsule OCT Endomicroscopy in the Primary Care Setting

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02445027
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arm: 1
• Actual Duration (Months): 66
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

The goal of this study is to test the feasibility and acceptability of tethered capsule Optical Coherence Tomography (OCT) endomicroscopy as a device for population-based screening in the primary care practice environment.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Device: MGH OCT Imaging Capsule	N/A

Detailed Description

60 healthy volunteers scheduled for a routine primary care visit will be recruited and asked to swallow the OCT capsule while being awake and unsedated. The capsule is attached to a tether which allows the operator to control as well as navigate the capsule as it progresses down the esophagus using natural propulsive force called peristalsis.

As the capsule progresses through the esophagus, multiple images of the esophagus are acquired and later analyzed.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: Pilot Study for Imaging of the Esophagus Using a Tethered Capsule OCT Endomicroscopy in the Primary Care Setting
• Actual Study Start Date: Sep 16, 2014
• Actual Primary Completion Date: Jan 30, 2018
• Actual Study Completion Date: Mar 18, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MGH OCT Imaging Capsule Subject will swallow the OCT capsule and images will be acquired using the OCT Imaging system.	Device: MGH OCT Imaging Capsule; Imaging of the esophagus using the OCT Capsule and system.

Outcome Measures

Primary Outcome Measures

1. Feasibility of Esophageal Imaging in Subjects Who Successfully Swallow the OCT Capsule in the Primary Care Setting. [Approximate 20min visit (5min image acquisition)]

   Number of Participants able to swallow the capsule successfully. An investigator will assess the quality of the recorded images and movies obtained with each exam after imaging has been completed. This is a feasibility study and was not used for any diagnosis.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subjects must be scheduled for non-urgent appointment at primary care practice including annual wellness visits and routine follow-up appointments.

• 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.

Exclusion Criteria:

• Subjects with current symptoms of dysphagia

• Subjects with any history of intestinal strictures, prior GI surgery, or history of intestinal Crohn's disease.

• Subjects with current symptoms of fever, nausea or sore throat at the time of the appointment.

• Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital

Investigators

• Principal Investigator: Guillermo Tearney, MD., PhD, Massachusetts General Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 4, 2017

More Information

Publications

None provided.

• Responsible Party: Guillermo Tearney, Principal Investigator, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT02445027
• Other Study ID Numbers: 2014-P001519
• First Posted: May 15, 2015
• Last Update Posted: Oct 19, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Guillermo Tearney, Principal Investigator, Massachusetts General Hospital: Primary Care; Healthy

Study Results

Participant Flow

Recruitment Details	A total number of 60 Participants were enrolled in the study

Arm/Group Title	Feasibility of Tethered Capsule Endomicroscopy
Arm/Group Description	Number of participants able to swallow the capsule and capture OCT images successfully in the PCP setting.
Period Title: Overall Study
STARTED	60
COMPLETED	45
NOT COMPLETED	15

Baseline Characteristics

Arm/Group Title	Feasibility
Arm/Group Description	Number of participants able to swallow the capsule and capture OCT images successfully.
Overall Participants	60
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	14 23.3%
>=65 years	46 76.7%
Sex: Female, Male (Count of Participants)
Female	35 58.3%
Male	25 41.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	3 5%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	6 10%
White	49 81.7%
More than one race	2 3.3%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	60 100%

Outcome Measures

1. Primary Outcome

Title	Feasibility of Esophageal Imaging in Subjects Who Successfully Swallow the OCT Capsule in the Primary Care Setting.
Description	Number of Participants able to swallow the capsule successfully. An investigator will assess the quality of the recorded images and movies obtained with each exam after imaging has been completed. This is a feasibility study and was not used for any diagnosis.
Time Frame	Approximate 20min visit (5min image acquisition)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Feasibility
Arm/Group Description	Feasibility is measured by the total number of Participants able to swallow the capsule successfully.
Measure Participants	60
Count of Participants [Participants]	45 75%

Adverse Events

Time Frame	During the procedure and 10 minutes after
Adverse Event Reporting Description	The adverse events were collected systematically for this study. The definition of adverse events is the same as clinicaltrials.gov definition.
Arm/Group Title	MGH OCT Imaging Capsule
Arm/Group Description	Subject will swallow the OCT capsule and images will be acquired using the OCT Imaging system. MGH OCT Imaging Capsule: Imaging of the esophagus using the OCT Capsule and system.
All Cause Mortality
	MGH OCT Imaging Capsule
	Affected / at Risk (%)	# Events
Total	0/60 (0%)
Serious Adverse Events
	MGH OCT Imaging Capsule
	Affected / at Risk (%)	# Events
Total	0/60 (0%)
Other (Not Including Serious) Adverse Events
	MGH OCT Imaging Capsule
	Affected / at Risk (%)	# Events
Total	0/60 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.