A Prospective, Multicenter, Single-Arm, Pre-Market, Pivotal Study to Evaluate Safety and Efficacy of a Novel Motorized Spiral Enteroscope for Antegrade Enteroscopy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Small Bowel Disease
- Sponsor
- Olympus Corporation of the Americas
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Rate of device related serious adverse events
- Status
- Suspended
- Last Updated
- 3 years ago
Overview
Brief Summary
To evaluate safety and efficacy
Detailed Description
The purpose of this study is to evaluate the safety and efficacy of the PowerSpiral™ Enteroscopy System, when used in subjects undergoing antegrade (per-oral) enteroscopy of the small bowel.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient is ≥ 22 years of age
- •Medical indication for antegrade enteroscopy
- •Willing and able to provide informed consent
Exclusion Criteria
- •Any medical contraindication to standard enteroscopy
- •Any test that is done as part of the standard of care that would prevent the enteroscopy from being performed for safety reasons
- •Unable or unwilling to provide informed consent
- •Female and of child-bearing age who is currently pregnant or planning to become pregnant within the study period
- •Presence of any intra-luminal or extra-luminal foreign body in the abdominal cavity
- •Any prior gastric, small bowel or colonic surgery, or implantable devices in these locations (cardiac pacemakers and non-abdominal implants are acceptable)
- •Known or suspected bowel obstruction, or history of bowel obstruction
- •Taking anti-platelet agents or anticoagulants (other than aspirin) within last 7 days
- •Known coagulation disorder
- •Known or suspected esophageal stricture or Schatzki ring
Outcomes
Primary Outcomes
Rate of device related serious adverse events
Time Frame: 7 days
The primary safety endpoint will compare the rate of device related serious adverse events (SAE) reported in this study to the rate of device related SAEs reported in medical literature for the Spirus Medical Endo-Ease Discovery™ SB overtube
Maximum depth of endoscope insertion
Time Frame: Intraoperative
The primary efficacy endpoint will compare the maximum depth of enteroscope insertion for the study device to the maximum depth of enteroscope insertion data reported in medical literature for the Spirus Medical Endo-Ease Discovery™ SB overtube.
Secondary Outcomes
- Total procedure time(Intraoperative)
- Insertion time(Intraoperative)
- Withdrawn time(Intraoperative)
- Total enteroscopy rate(Intraoperative)
- Diagnostic yield(Intraoperative)
- Adverse events(7 days post-procedure)
- Device deficiencies(Intraoperative)