The PowerSpiral Antegrade Investigational Device Exemption (IDE) Study
- Conditions
- Small Bowel Disease
- Interventions
- Device: PowerSpiral Enteroscopy System
- Registration Number
- NCT03990207
- Lead Sponsor
- Olympus Corporation of the Americas
- 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.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 100
- Patient is ≥ 22 years of age
- Medical indication for antegrade enteroscopy
- Willing and able to provide informed consent
- 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
- Known gastric or esophageal varices
- Suspected perforation of the gastrointestinal (GI) tract
- Previous abdominal radiation
- Inability to tolerate general anesthesia for any reason
- Inability to tolerate endotracheal intubation
- Known need for endoscopic retrograde cholangiopancreatography (ERCP) during enteroscopy
- American Society of Anesthesiologists (ASA) Classification 4 or greater
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PowerSpiral Enteroscopy System PowerSpiral Enteroscopy System Subjects who have a medical indication for antegrade enteroscopy
- Primary Outcome Measures
Name Time Method Rate of device related serious adverse events 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 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 Outcome Measures
Name Time Method Total procedure time Intraoperative Measured from initial enteroscope introduction through the bite block to final enteroscope withdrawal through the bite block in minutes.
Insertion time Intraoperative Measured from the initial enteroscope introduction through the bite block to maximum depth of enteroscope insertion measured in minutes
Withdrawn time Intraoperative Measured from maximum depth of enteroscope insertion excluding any time spent on therapeutic interventions, to final enteroscope withdrawal through bite block measured in minutes.
Total enteroscopy rate Intraoperative Percentage of subjects where the entire small intestine is intubated with the enteroscopy from pylorus to cecum.
Diagnostic yield Intraoperative Percentage of subjects where enteroscopy produces the findings required to establish diagnosis.
Adverse events 7 days post-procedure SAEs regardless of relationship to study device and/or procedure, and non-SAEs related to study device and/or procedure
Device deficiencies Intraoperative Number of device deficiencies during the enteroscopy procedure
Trial Locations
- Locations (1)
Olympus Corporation of the Americas
🇺🇸Southborough, Massachusetts, United States