Feasibility Study to Evaluate the Performance of Flocculation-Adsorption System for Colon Cleansing Enhancement (RD-400)

Medtronic

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Other: Cleaning capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT01370759

CTIL - RD-400

Details and patient eligibility

About

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

Full description

To ensure the success of a PillCamTM Colon examination, as standard practice, patients are requested to adhere to a bowel preparation procedure.

The study is designed to evaluate the performance and contribution of a flocculation-adsorption system to colon cleansing.

Enrollment: 81 patients

Sex: All

Ages: 23 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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81 participants in 1 patient group

Colon-targeted cleaning capsule

Experimental group

Treatment:

Other: Cleaning capsule