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

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.

Study Overview

• Status: Terminated
• Conditions: Healthy
• Intervention / Treatment: Device: PillCam™ Endoscopy System; Drug: Bowel prep combination

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.

• Study Type: Interventional
• Enrollment (Actual): 694
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Yoqne'am 'Illit, Israel
    • Medtronic - Glilee Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: PillCam™ Endoscopy System; PillCam™ Endoscopy System consists of the following subunits: PillCam™ Capsule products' family:PillCam™ COLON 2PillCam™ UGI (upper gastrointestinal)PillCam™ SB3 (small bowel 3)PillCam™ Crohn's capsule; Patency capsule: PillCam™ Patency capsule All the bellow system subunits are part of the Pillcam™ systems: PillCam™ Recorder; PillCam™ Sensor Arrays & Sensor Belt; PillCam™ Software v. 9; Workstation unit

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All device related Adverse events will be collected and reported in order to assess the device safety.	All device related Adverse events will be reported by number, type, seriousness, severity and duration. All device related adverse events will be captured, regardless of severity.	Up to 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of raw data generation in the data recorder by confirming presence of the procedure raw data output files (technical outcome)	A PillCam procedure will be assessed for raw data generation in the data recorder (similar to standard of care procedure), by confirming presence of the procedure output files (technical outcome). A nominal scale of Yes/No will be used to determine whether the raw data has been generated by the data recorder or not.	Up to 10 years

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: Wisam Sbeit, M.D, Galil MC, Nahariya

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2018
• Primary Completion (Actual): March 27, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: September 29, 2017
• First Submitted That Met QC Criteria: September 29, 2017
• First Posted (Actual): October 4, 2017

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: MDT16024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No