NCT00885339

Brief Summary

The purpose of this study is to compare two preparation and procedure in order to develop the most optimal capsule procedure in regards to colon cleansing level and capsule excretion rate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

4 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

Study Start

First participant enrolled

February 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 21, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

July 31, 2019

Status Verified

March 1, 2010

Enrollment Period

1.7 years

First QC Date

April 20, 2009

Last Update Submit

July 29, 2019

Conditions

Colonic Diseases

Keywords

Colonic Diseases

Outcome Measures

Primary Outcomes (2)

  • Colon cleansing level score

    within 7 days

  • Number of colon capsules excreted over time

    within 7 days

Secondary Outcomes (4)

  • Accuracy parameters of PCCE, compared to colonoscopy.

    within 7 days

  • Number, type and severity of adverse events

    within 7 days

  • Patient subjective assessment questionnaires

    within 7 days

  • Physician assessment questionnaire

    within 7 days

Study Arms (1)

A

Patients that are indicated for colonoscopy, who are suspected or known to suffer from colonic diseases.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients that are indicated for colonoscopy, who are suspected or known to suffer from colonic diseases

You may qualify if:

  • Subject is between the ages of 18-75 years.
  • Subject is referred for colonoscopy as clinically indicated for any reason. This may include, but not limited to, the investigation of any of the following conditions: rectal bleeding, melena, positive stool testing for occult blood, recent change of bowel habits, screening for colorectal cancer, ulcerative colitis, colonic findings on an imaging study)

You may not qualify if:

  • The presence of any of the following will exclude a subject from study enrollment:
  • Subject has dysphagia or any swallowing disorder
  • Subject has Congestive heart failure
  • Subject has high degree of renal insufficiency
  • Subject has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator
  • Subject has a cardiac pacemaker or other implanted electromedical device.
  • Subject has any allergy or other known contraindication to the medications used in the study
  • Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
  • Subject with any condition believed to have an increased risk for capsule retention such as Crohn's disease, intestinal tumors, radiation enteritis, or NSAID enteropathy,
  • Subject has any condition, which precludes compliance with study and/or device instructions.
  • Women who are either pregnant or nursing at the time of screening, who intend to be during the study period, or are of child-bearing potential and do not practice medically acceptable methods of contraception.
  • Subject suffers from life threatening conditions
  • Subject currently participating in another clinical study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Centro Ricerca e Formazione ad Alta Tecnologia nelle Scienze Bomediche

Campobasso, 86100, Italy

Location

Humanitas Istituto Clinico

Milan, 20089, Italy

Location

Ospedale Maggiore - Policlinico

Milan, 2100, Italy

Location

Universita Cattolica del Sacro Cuore

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Colonic Diseases

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Guido Costamagna, Prof. Dr.

    Catholic University of the Sacred Heart

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2009

First Posted

April 21, 2009

Study Start

February 1, 2008

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

July 31, 2019

Record last verified: 2010-03

Locations

IT(4)