NCT01370759

Brief Summary

The purpose of this study is to demonstrate feasibility of enhancing colon cleansing.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
81

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Sep 2011

Longer than P75 for phase_1 healthy

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 9, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 10, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

July 31, 2019

Status Verified

April 1, 2014

Enrollment Period

2.6 years

First QC Date

June 9, 2011

Last Update Submit

July 29, 2019

Conditions

Healthy

Keywords

bowel prepPillCam

Outcome Measures

Primary Outcomes (1)

  • Cleansing grading

    within 10 days

Secondary Outcomes (2)

  • Distribution of time

    within 10 days

  • GI tract segment of capsule disintegration

    within 10 days

Study Arms (1)

Colon-targeted cleaning capsule

EXPERIMENTAL
Other: Cleaning capsule

Interventions

Cleaning capsuleOTHER

Capsules containing the tested materials aimed to improve colon cleansing

Also known as: Active cleaning capsules
Colon-targeted cleaning capsule

Eligibility Criteria

Age23 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject's age is between 23-75 years.
  • Subject is healthy.
  • Subject agrees to sign the Informed Consent Form

You may not qualify if:

  • Contraindication to capsule endoscopy
  • Contraindication or allergy to any of the products and materials used for bowel preparation
  • Subject is not able to provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Medical center

Haifa, Israel

Location

Study Officials

  • Ian Gralnek, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2011

First Posted

June 10, 2011

Study Start

September 1, 2011

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

July 31, 2019

Record last verified: 2014-04

Locations

IL(1)