NCT01879943

Brief Summary

The study will compare the diagnostic efficacy of the VCC (PillCam COLON 2) to standard colonoscopy in patients with prior colorectal surgery. The hypothesis is to validate the VCC as a means of screening for colonic polyps after resection, which would avoid a colonoscopy with its associated general anesthesia and potential side effects.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
37

participants targeted

Target at below P25 for not_applicable colorectal-cancer

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
terminated

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

June 14, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 18, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

October 18, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2016

Completed
Last Updated

April 10, 2019

Status Verified

April 1, 2019

Enrollment Period

2.6 years

First QC Date

June 14, 2013

Last Update Submit

April 9, 2019

Conditions

Colorectal Cancer

Keywords

Colorectal cancerFollow upColonoscopyVideocapsule

Outcome Measures

Primary Outcomes (1)

  • Number of patients with full colonic exploration and detection of lesions

    Number of patients for whom the capsule allowed for full colonic exploration and presence/absence of colorectal lesions detected by VCC compared to conventional colonoscopy

    By the end of both procedures (Day 1)

Secondary Outcomes (7)

  • Anastomosis visualization

    Prior to colonoscopy on Day 1

  • Number and size of detected lesions

    By the end of both procedures (Day 1)

  • Quality of colic preparation

    By the end of both procedures (Day 1)

  • Times related to videocapsule

    Prior to colonoscopy on Day 1

  • Adverse events related to VCC exam and colonoscopy

    Until end of Day 1

  • +2 more secondary outcomes

Study Arms (1)

PillCam COLON 2 and Standard Colonoscopy

EXPERIMENTAL

Patients will have videocapsule colonoscopy after bowel preparation, followed by standard colonoscopy the next day. Interventions: * Device: PillCam COLON 2 on D0 * Procedure: Standard colonoscopy on D1

Device: PillCam Colon 2Procedure: Colonoscopy

Interventions

PillCam Colon 2DEVICE

PillCam® COLON 2 capsule endoscopy is a minimally invasive tool for direct visualization of the colon, including identifying the occurrence of polyps.

PillCam COLON 2 and Standard Colonoscopy
ColonoscopyPROCEDURE

Standard colonoscopy is the standard against which capsule endoscopy is compared.

PillCam COLON 2 and Standard Colonoscopy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient between 18 and 85 years old
  • patient with greater than 3 month follow-up for colorectal resection with ileo-colic , colo-colic or colorectal anastomosis, regardless of etiology
  • patient requiring a colonoscopy for regular medical care
  • absence of contra-indication to anesthesia and to colonoscopy conduct
  • patient able to understand the study related information and to provide written informed consent
  • patient registered with the French social security regime
  • absence of written informed consent
  • patient having had a total colectomy
  • patient with terminal stoma
  • patient with clinical suspicion of intestinal stenosis and/or anastomotic stenosis
  • patient with known Zenker diverticulum
  • patient wearing a pacemaker or any other internal electronic medical device
  • patient with deglutition disorders and/or altered state of consciousness
  • patient with serious disease preventing planned study procedures
  • pregnant or breast-feeding woman
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hepato-Gastroenterology, Nouvel Hopital Civil

Strasbourg, 67000, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Michel Delvaux, MD

    Department of Hepato-Gastroenterology, Nouvel Hopital Civil, Strasbourg, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2013

First Posted

June 18, 2013

Study Start

October 18, 2013

Primary Completion

June 8, 2016

Study Completion

June 8, 2016

Last Updated

April 10, 2019

Record last verified: 2019-04

Locations

FR(1)