Not moving forward with the study at this time. No subject were consented or enrolled

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