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Clinical Trial Summary

This is a feasibility, prospective, single center, open label, uncontrolled clinical study, to evaluate the safety and preliminary efficacy of the different R&D changes made and implemented in the existing PillCam Capsule products family, PillCam Endoscopy System subunits, the Patency system and bowel preparation procedure.

Clinical Trial Description

The study consists of a screening - enrollment phase, a possible preparation phase followed by the PillCam Endoscopy or Patency procedure visit and a post procedure telephone, follow up visit.

Subjects may be assigned to any of the testing's done within this study as long as they fulfill all the inclusion and exclusion criteria's and depends on their availability and their willingness to participate in a specific testing. The decision to assign a subject to a specific testing is done based on subject's availability.

Each subject may ingest up to 15 capsules (PillCam, Patency) during his/her participation in the study, each ingestion will be separated in between by at least two weeks interval. A following capsule may be ingested only upon verification of previous capsule excretion.

In general, under the study protocol, per a single procedure, each subject will undergo a possible preparation phase followed by the PillCam endoscopy or Patency procedure and telephone follow up visit. Overall the expected duration for subject's participation in the study is expected to be up to 5 years, until subject will complete up to 15 PillCam Capsule ingestions.

Subject may withdraw consent at any time and will be considered as completed once completed at least one capsule ingestion (PillCam or Patency) or completed one of the possible procedures which are not involving capsule ingestion during the study period. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03301909
Study type Interventional
Source Medtronic - MITG
Contact Eti Ganon-Elazar, PhD
Phone +972-4-9097742
Status Recruiting
Phase N/A
Start date April 10, 2018
Completion date November 2022

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