NCT03990207

Brief Summary

To evaluate safety and efficacy

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 18, 2019

Completed
3.1 years until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

August 5, 2022

Status Verified

August 1, 2022

Enrollment Period

10 months

First QC Date

June 11, 2019

Last Update Submit

August 3, 2022

Conditions

Small Bowel Disease

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • Total procedure time

    Intraoperative

  • Insertion time

    Intraoperative

  • Withdrawn time

    Intraoperative

  • Total enteroscopy rate

    Intraoperative

  • Diagnostic yield

    Intraoperative

  • +2 more secondary outcomes

Study Arms (1)

PowerSpiral Enteroscopy System

EXPERIMENTAL

Subjects who have a medical indication for antegrade enteroscopy

Device: PowerSpiral Enteroscopy System

Interventions

PowerSpiral Enteroscopy SystemDEVICE

Motorized spiral enteroscopy system

PowerSpiral Enteroscopy System

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient is ≥ 22 years of age
  • Medical indication for antegrade enteroscopy
  • Willing and able to provide informed consent

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Olympus Corporation of the Americas

Southborough, Massachusetts, 01772, United States

Location

Related Publications (4)

  • 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.

    PMID: 28652176BACKGROUND

  • 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.

    PMID: 20861800BACKGROUND

  • 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.

    PMID: 20619404BACKGROUND

  • 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.

    PMID: 22704571BACKGROUND

Study Officials

  • Daniel DeMarco, MD

    Baylor Health Care System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2019

First Posted

June 18, 2019

Study Start

August 1, 2022

Primary Completion

June 1, 2023

Study Completion

October 1, 2023

Last Updated

August 5, 2022

Record last verified: 2022-08

Locations

US(1)