search
Back to results

The PowerSpiral Antegrade Investigational Device Exemption (IDE) Study

Primary Purpose

Small Bowel Disease

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PowerSpiral Enteroscopy System
Sponsored by
Olympus Corporation of the Americas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Small Bowel Disease

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Olympus Corporation of the Americas

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PowerSpiral Enteroscopy System

Arm Description

Subjects who have a medical indication for antegrade enteroscopy

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Total procedure time
Measured from initial enteroscope introduction through the bite block to final enteroscope withdrawal through the bite block in minutes.
Insertion time
Measured from the initial enteroscope introduction through the bite block to maximum depth of enteroscope insertion measured in minutes
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.
Total enteroscopy rate
Percentage of subjects where the entire small intestine is intubated with the enteroscopy from pylorus to cecum.
Diagnostic yield
Percentage of subjects where enteroscopy produces the findings required to establish diagnosis.
Adverse events
SAEs regardless of relationship to study device and/or procedure, and non-SAEs related to study device and/or procedure
Device deficiencies
Number of device deficiencies during the enteroscopy procedure

Full Information

First Posted
June 11, 2019
Last Updated
August 3, 2022
Sponsor
Olympus Corporation of the Americas
Collaborators
Baylor Research Institute, University of Massachusetts, Worcester, University of Florida, AdventHealth, Rhode Island Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03990207
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Suspended
Why Stopped
Not moving forward with the study at this time. No subject were consented or enrolled
Study Start Date
August 2022 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Olympus Corporation of the Americas
Collaborators
Baylor Research Institute, University of Massachusetts, Worcester, University of Florida, AdventHealth, Rhode Island Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Bowel Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PowerSpiral Enteroscopy System
Arm Type
Experimental
Arm Description
Subjects who have a medical indication for antegrade enteroscopy
Intervention Type
Device
Intervention Name(s)
PowerSpiral Enteroscopy System
Intervention Description
Motorized spiral enteroscopy system
Primary Outcome Measure Information:
Title
Rate of device related serious adverse events
Description
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
Time Frame
7 days
Title
Maximum depth of endoscope insertion
Description
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.
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Total procedure time
Description
Measured from initial enteroscope introduction through the bite block to final enteroscope withdrawal through the bite block in minutes.
Time Frame
Intraoperative
Title
Insertion time
Description
Measured from the initial enteroscope introduction through the bite block to maximum depth of enteroscope insertion measured in minutes
Time Frame
Intraoperative
Title
Withdrawn time
Description
Measured from maximum depth of enteroscope insertion excluding any time spent on therapeutic interventions, to final enteroscope withdrawal through bite block measured in minutes.
Time Frame
Intraoperative
Title
Total enteroscopy rate
Description
Percentage of subjects where the entire small intestine is intubated with the enteroscopy from pylorus to cecum.
Time Frame
Intraoperative
Title
Diagnostic yield
Description
Percentage of subjects where enteroscopy produces the findings required to establish diagnosis.
Time Frame
Intraoperative
Title
Adverse events
Description
SAEs regardless of relationship to study device and/or procedure, and non-SAEs related to study device and/or procedure
Time Frame
7 days post-procedure
Title
Device deficiencies
Description
Number of device deficiencies during the enteroscopy procedure
Time Frame
Intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel DeMarco, MD
Organizational Affiliation
Baylor Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Olympus Corporation of the Americas
City
Southborough
State/Province
Massachusetts
ZIP/Postal Code
01772
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28652176
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.
Results Reference
background
PubMed Identifier
20861800
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.
Results Reference
background
PubMed Identifier
20619404
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.
Results Reference
background
PubMed Identifier
22704571
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.
Results Reference
background

Learn more about this trial

The PowerSpiral Antegrade Investigational Device Exemption (IDE) Study

We'll reach out to this number within 24 hrs