The PowerSpiral Antegrade Investigational Device Exemption (IDE) Study

Olympus

Status

Suspended

Conditions

Small Bowel Disease

Treatments

Device: PowerSpiral Enteroscopy System

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03990207

2018-OCA-01

Details and patient eligibility

About

To evaluate safety and efficacy

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

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
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