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

Study Overview

• Status: Suspended
• Conditions: Small Bowel Disease
• Intervention / Treatment: Device: PowerSpiral Enteroscopy System

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Southborough, Massachusetts, United States, 01772
      • Olympus Corporation of the Americas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PowerSpiral Enteroscopy System; Subjects who have a medical indication for antegrade enteroscopy	Device: PowerSpiral Enteroscopy System; Motorized spiral enteroscopy system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of device related serious adverse events	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	7 days
Maximum depth of endoscope insertion	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.	Intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total procedure time	Measured from initial enteroscope introduction through the bite block to final enteroscope withdrawal through the bite block in minutes.	Intraoperative
Insertion time	Measured from the initial enteroscope introduction through the bite block to maximum depth of enteroscope insertion measured in minutes	Intraoperative
Withdrawn time	Measured from maximum depth of enteroscope insertion excluding any time spent on therapeutic interventions, to final enteroscope withdrawal through bite block measured in minutes.	Intraoperative
Total enteroscopy rate	Percentage of subjects where the entire small intestine is intubated with the enteroscopy from pylorus to cecum.	Intraoperative
Diagnostic yield	Percentage of subjects where enteroscopy produces the findings required to establish diagnosis.	Intraoperative
Adverse events	SAEs regardless of relationship to study device and/or procedure, and non-SAEs related to study device and/or procedure	7 days post-procedure
Device deficiencies	Number of device deficiencies during the enteroscopy procedure	Intraoperative

Collaborators and Investigators

• Sponsor: Olympus Corporation of the Americas
• Collaborators: University of Florida; Rhode Island Hospital; University of Massachusetts, Worcester; AdventHealth; Baylor Research Institute
• Investigators: Principal Investigator: Daniel DeMarco, MD, Baylor Health Care System

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2022
• Primary Completion (ANTICIPATED): June 1, 2023
• Study Completion (ANTICIPATED): October 1, 2023

Study Registration Dates

• First Submitted: June 11, 2019
• First Submitted That Met QC Criteria: June 17, 2019
• First Posted (ACTUAL): June 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 3, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases
• Other Study ID Numbers: 2018-OCA-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes