Clinical trial NCT03990207: The PowerSpiral Antegrade Investigational Device Exemption (IDE) Study
Official title: A Prospective, Multicenter, Single-Arm, Pre-Market, Pivotal Study to Evaluate Safety and Efficacy of a Novel Motorized Spiral Enteroscope for Antegrade Enteroscopy
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Small Bowel Disease
Lead sponsor: Olympus Corporation of the Americas
Sponsor class: INDUSTRY
Collaborators: name: Baylor Research Institute
name: University of Massachusetts, Worcester
name: University of Florida
name: AdventHealth
name: Rhode Island Hospital
First posted: 2019-06-18
Enrollment: 100
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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
* 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

Primary outcomes:
measure: Rate of device related serious adverse events
timeFrame: 7 days
measure: Maximum depth of endoscope insertion
timeFrame: Intraoperative
Secondary outcomes:
measure: Total procedure time
timeFrame: Intraoperative
measure: Insertion time
timeFrame: Intraoperative
measure: Withdrawn time
timeFrame: Intraoperative
measure: Total enteroscopy rate
timeFrame: Intraoperative
measure: Diagnostic yield
timeFrame: Intraoperative
measure: Adverse events
timeFrame: 7 days post-procedure
measure: Device deficiencies
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Southborough
country: United States
facility: Olympus Corporation of the Americas
state: Massachusetts
Study officials:
affiliation: Baylor Health Care System
name: Daniel DeMarco, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baniya R, Upadhaya S, Subedi SC, Khan J, Sharma P, Mohammed TS, Bachuwa G, Jamil LH. Balloon enteroscopy versus spiral enteroscopy for small-bowel disorders: a systematic review and meta-analysis. Gastrointest Endosc. 2017 Dec;86(6):997-1005. doi: 10.1016/j.gie.2017.06.015. Epub 2017 Jun 23.
citation: Buscaglia JM, Richards R, Wilkinson MN, Judah JR, Lam Y, Nagula S, Draganov PV. Diagnostic yield of spiral enteroscopy when performed for the evaluation of abnormal capsule endoscopy findings. J Clin Gastroenterol. 2011 Apr;45(4):342-6. doi: 10.1097/MCG.0b013e3181eeb74b.
citation: Khashab MA, Lennon AM, Dunbar KB, Singh VK, Chandrasekhara V, Giday S, Canto MI, Buscaglia JM, Kapoor S, Shin EJ, Kalloo AN, Okolo PI 3rd. A comparative evaluation of single-balloon enteroscopy and spiral enteroscopy for patients with mid-gut disorders. Gastrointest Endosc. 2010 Oct;72(4):766-72. doi: 10.1016/j.gie.2010.04.043. Epub 2010 Jul 8.
citation: Akerman PA, Haniff M. Spiral enteroscopy: prime time or for the happy few? Best Pract Res Clin Gastroenterol. 2012 Jun;26(3):293-301. doi: 10.1016/j.bpg.2012.03.008.