NCT04246632

Brief Summary

This non-significant risk pilot study is designed to evaluate safety and performance of the CapsoCam® Colon capsule endoscope in patients who meet the eligibility criteria and are scheduled for colonoscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

3 active sites

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

January 24, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

January 25, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2021

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2021

Completed
Last Updated

August 6, 2021

Status Verified

August 1, 2021

Enrollment Period

1.1 years

First QC Date

January 24, 2020

Last Update Submit

August 2, 2021

Conditions

Colonoscopy

Outcome Measures

Primary Outcomes (1)

  • Efficacy Assessments

    Determine the Accuracy of CapsoCam® to detect and measure size of colon polyps relative to the colonoscopy procedure.

    Day 1

Secondary Outcomes (1)

  • Safety Assessments: Incidence of device related serious adverse events (SAEs) and unanticipated adverse device effects (UADEs)

    Day 1-3

Study Arms (1)

Open label

EXPERIMENTAL

Single arm study, all subjects receive device

Device: CapsoCam Colon Capsule Endoscopy

Interventions

CapsoCam Colon Capsule EndoscopyDEVICE

CapsoCam® Colon is intended to provide visualization of the colon and the detection of colon polyps in adults.

Open label

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between the ages of 50 and 75 years old
  • Subject meets at least one of the following criteria for increased risk for polyps:
  • Recent history (within 6 months) of positive FIT/iFOBT or Cologuard test
  • Older than 55 years of age, without prior history of colonoscopy
  • Has had a positive colonoscopy ≥ 5 years prior to screening visit
  • And/or having at least two of the following risk factors:
  • Current smoker
  • BMI of ≥30
  • Family history (blood relative) of colorectal cancer
  • Sedentary lifestyle
  • Low fiber/ high fat diet
  • No contraindication for capsule endoscopy or colonoscopy
  • Committed to undergo a colonoscopy, independent of this study within 8 weeks of Capsule ingestion
  • Choose to participate and must have signed the IRB-approved informed-consent document and agreed to release colonoscopy images and results report to Sponsor

You may not qualify if:

  • History of negative colonoscopy within the last 10 years
  • History of incomplete colonoscopy
  • Impaired cardiac function assessed as greater than NYHA Class II
  • History of small- or large-bowel obstructive condition
  • Known history of Crohn's disease, swallowing disorder, ulcerative colitis, ischemic bowel disease and/or radiation enteritis
  • Known history of NSAID enteropathy and stricture resulting from taking NSAIDs on a regular basis that, in the opinion of the Investigator, would put the patient at greater risk for capsule endoscope retention
  • Unable to follow or tolerate fasting, bowel preparation, and other study procedures
  • Known allergy to ingredients used in bowel preparation and boosters
  • Daily and/or regular use of narcotics
  • Known or suspected AIDS
  • Uncompensated cirrhosis
  • Prior abdominal radiation therapy
  • Diagnosis of anorexia or bulimia
  • Known or suspected megacolon
  • Scheduled to undergo MRI examination within 7 days after ingestion of the capsule
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Silicon Valley Research Institute, Inc.

San Jose, California, 95116, United States

Location

CapsoVision Research Clinic

Saratoga, California, 95070, United States

Location

West Michigan Clinical Research Center

Wyoming, Michigan, 49519, United States

Location

MeSH Terms

Interventions

Endoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
PI is masked to Capsule results and capsule reader is masked to colonoscopy results.
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Multi-Center; Prospective, Open Label, Non-Significant Risk, Pilot Study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2020

First Posted

January 29, 2020

Study Start

January 25, 2020

Primary Completion

February 25, 2021

Study Completion

March 15, 2021

Last Updated

August 6, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

All IPD will be kept confidential. Safety events/concerns will be shared will all sites without exposing PHI.

Locations

US(3)