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

NCT03301909 | Terminated

• 1 other identifier: MDT16024
• Study Type: interventional
• Target: 694
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assessment of raw data generation in the data recorder by confirming presence of the procedure raw data output files (technical outcome)

  Up to 10 years

Study Arms (1)

PillCam™ Endoscopy System

EXPERIMENTAL

PillCam™ Endoscopy System consists of the following subunits: * PillCam™ Capsule products' family: 1. PillCam™ COLON 2 2. PillCam™ UGI (upper gastrointestinal) 3. PillCam™ SB3 (small bowel 3) 4. 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; Drug: Bowel prep combination

Interventions

PillCam™ Endoscopy System DEVICE

Subject may be assigned to any procedure involving modification of any of the PillCam™ Endoscopy System component as listed in the arm description.

PillCam™ Endoscopy System

Bowel prep combination DRUG

Subject may be assigned to any bowel preparation combination.

PillCam™ Endoscopy System

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject either male or female is 45-85 years of age.
• The subject is in good general health to enable participation in the study.
• The subject received an explanation and understands the nature of the study and agrees to provide written informed consent.

You may not qualify if:

• Subject has dysphagia or any swallowing disorder.
• Subject is known or is suspected to suffer from intestinal obstruction or stricture (symptoms such as severe abdominal pain with accompanying nausea or vomiting).
• Subject with known gastrointestinal motility disorders.
• Subjects with known or suspected delayed gastric emptying.
• Subject has known or suspected Crohn's disease, other inflammatory bowel disease, perforations or structural disorders of the gut wall.
• Subject has diabetes.
• 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.
• Subject has any allergy or other contraindication to any materials including preparation used prior, during or after capsule endoscopy in the study.
• Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
• Subject has severe congestive heart failure or known renal or hepatic insufficiency.
• Subject has a cardiac pacemakers or other implanted electromedical devices.
• Subject has any condition, which according to the investigators judgment, precludes compliance with study and/or device instructions.
• 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.
• Subject is currently participating in another clinical study that may directly or indirectly affect the results of this study.
• Subject is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity).

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (1)

Medtronic - Glilee Medical Center

Yokneam Illit, Israel

Location

Study Officials

• Wisam Sbeit, M.D

  Galil MC, Nahariya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2017
• First Posted: October 4, 2017
• Study Start: April 10, 2018
• Primary Completion: March 27, 2023
• Study Completion: March 31, 2023
• Last Updated: January 10, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)