NCT03301909

Development of Applications of PillCam™ Endoscopy and Patency Systems and Clinical Evaluation of Their Performance in Healthy Volunteers ("HEIGHT" Study)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 694 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 45 Years – 85 Years
• Healthy volunteers: Accepted

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.

Detailed 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 sub-assays done within this study as long as they fulfill all the inclusion and exclusion criteria and depends on their availability and their willingness to participate in a specific sub-assay. Each subject may participate in up to 15 sub-assays 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. Subjects can participate in a specific sub-assay only once. 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 10 years, until subject will complete participation in up to 15 sub-assays. 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DEVICE	PillCam™ Endoscopy System	Subject may be assigned to any procedure involving modification of any of the PillCam™ Endoscopy System component as listed in the arm description.
DRUG	Bowel prep combination	Subject may be assigned to any bowel preparation combination.

Timeline

• Start date: 2018-04-10
• Primary completion: 2023-03-27
• Completion: 2023-03-31
• First posted: 2017-10-04
• Last updated: 2024-01-10

Locations

1 site across 1 country: Israel