Status:
TERMINATED
Development of Applications of PillCam™ Endoscopy and Patency Systems and Clinical Evaluation of Their Performance in Healthy Volunteers ("HEIGHT" Study)
Lead Sponsor:
Medtronic - MITG
Conditions:
Healthy
Eligibility:
All Genders
45-85 years
Phase:
NA
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 ex...
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. Subjec...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
April 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2023
Estimated Enrollment :
694 Patients enrolled
Trial Details
Trial ID
NCT03301909
Start Date
April 10 2018
End Date
March 31 2023
Last Update
January 10 2024
Active Locations (1)
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1
Medtronic - Glilee Medical Center
Yokneam Illit, Israel