The PowerSpiral Antegrade Investigational Device Exemption (IDE) Study

A Prospective, Multicenter, Single-Arm, Pre-Market, Pivotal Study to Evaluate Safety and Efficacy of a Novel Motorized Spiral Enteroscope for Antegrade Enteroscopy

To evaluate safety and efficacy

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.

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