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

• Status: Recruiting
• Trial end date: 2028-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medtronic - MITG

Criteria

Inclusion Criteria:

1. Subject either male or female is 45-85 years of age.

2. The subject is in good general health to enable participation in the study.

3. The subject received an explanation and understands the nature of the study and agrees to provide written informed consent.

Exclusion Criteria:

1. Subject has dysphagia or any swallowing disorder.

2. Subject is known or is suspected to suffer from intestinal obstruction or stricture (symptoms such as severe abdominal pain with accompanying nausea or vomiting).

3. Subject with known gastrointestinal motility disorders.

4. Subjects with known or suspected delayed gastric emptying.

5. Subject has known or suspected Crohn's disease, other inflammatory bowel disease, perforations or structural disorders of the gut wall.

6. Subject has diabetes.

7. Subject has undergone certain prior abdominal surgery of the gastrointestinal tract, (other than uncomplicated appendectomy or uncomplicated cholecystectomy) which may interfere with the study, such as small bowel or colonic resection. This will be evaluated by the investigator.

8. Subject has any allergy or other contraindication to any materials including preparation used prior, during or after capsule endoscopy in the study.

9. Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.

10. Subject has severe congestive heart failure or known renal or hepatic insufficiency.

11. Subject has a cardiac pacemakers or other implanted electromedical devices.

12. Subject has any condition, which according to the investigators judgment, precludes compliance with study and/or device instructions.

13. Females who are pregnant or nursing at the time of screening and/or during the study period, or are of child bearing potential without medically acceptable methods of contraception.

14. Subject is currently participating in another clinical study that may directly or indirectly affect the results of this study.

15. Subject is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity).