NCT02720848

Brief Summary

This is a randomized clinical trial examining the use of a stiffening wire to increase depth of maximal insertion during double and single balloon enteroscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 22, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 28, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2022

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2023

Completed
Last Updated

October 5, 2023

Status Verified

October 1, 2023

Enrollment Period

6.5 years

First QC Date

March 22, 2016

Last Update Submit

October 4, 2023

Conditions

Small Intestine Problem

Keywords

double-balloon enteroscopy

Outcome Measures

Primary Outcomes (1)

  • Distance gained beyond depth of maximal insertion 1

    Defined as the distance between depth of maximal insertion 1 and depth of maximal insertion 2. In cases where there is no depth of maximal insertion 2, a value of zero will be assigned. Distance will be measured using the fold counting method as follows: distance = # fold x 0.904 cm/fold.

    Measured once at the time of endoscopy

Secondary Outcomes (5)

  • Final depth of insertion

    Measured once at the time of endoscopy

  • Small bowel diagnostic rate

    Measured once at the time of endoscopy

  • Small bowel intervention rate

    Measured once at the time of endoscopy

  • Patient comfort survey

    Measured once at the time of endoscopy

  • Serious Adverse events

    Measured once at the time of endoscopy

Study Arms (2)

Stiffening wire

EXPERIMENTAL

A stiffening wire inserted into the instrument channel of the double/single balloon enteroscope will be used.

Device: Stiffening wire

Standard technique

ACTIVE COMPARATOR

The double/single balloon enteroscope will be used without the stiffening wire as per standard technique.

Device: Standard technique

Interventions

Stiffening wireDEVICE

The stiffening wire will be inserted into the double/single balloon enteroscope.

Stiffening wire
Standard techniqueDEVICE

The double/single balloon enteroscope will be used without the stiffening wire as per standard technique.

Standard technique

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient undergoing antegrade DBE/SBE.

You may not qualify if:

  • Age \< 18
  • Prior surgery involving resection of the esophagus, stomach, or small bowel
  • Suspected stricture or mass in any part of the gastrointestinal tract
  • Failure to obtain informed consent from the patient or substitute decision maker
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Related Publications (11)

  • Yamamoto H, Sekine Y, Sato Y, Higashizawa T, Miyata T, Iino S, Ido K, Sugano K. Total enteroscopy with a nonsurgical steerable double-balloon method. Gastrointest Endosc. 2001 Feb;53(2):216-20. doi: 10.1067/mge.2001.112181.

    PMID: 11174299BACKGROUND

  • Yamamoto H, Kita H, Sunada K, Hayashi Y, Sato H, Yano T, Iwamoto M, Sekine Y, Miyata T, Kuno A, Ajibe H, Ido K, Sugano K. Clinical outcomes of double-balloon endoscopy for the diagnosis and treatment of small-intestinal diseases. Clin Gastroenterol Hepatol. 2004 Nov;2(11):1010-6. doi: 10.1016/s1542-3565(04)00453-7.

    PMID: 15551254BACKGROUND

  • May A, Nachbar L, Ell C. Double-balloon enteroscopy (push-and-pull enteroscopy) of the small bowel: feasibility and diagnostic and therapeutic yield in patients with suspected small bowel disease. Gastrointest Endosc. 2005 Jul;62(1):62-70. doi: 10.1016/s0016-5107(05)01586-5.

    PMID: 15990821BACKGROUND

  • Hartmann D, Eickhoff A, Tamm R, Riemann JF. Balloon-assisted enteroscopy using a single-balloon technique. Endoscopy. 2007 Feb;39 Suppl 1:E276. doi: 10.1055/s-2007-966616. Epub 2007 Oct 24. No abstract available.

    PMID: 17957636BACKGROUND

  • Kawamura T, Yasuda K, Tanaka K, Uno K, Ueda M, Sanada K, Nakajima M. Clinical evaluation of a newly developed single-balloon enteroscope. Gastrointest Endosc. 2008 Dec;68(6):1112-6. doi: 10.1016/j.gie.2008.03.1063. Epub 2008 Jul 2.

    PMID: 18599052BACKGROUND

  • Domagk D, Mensink P, Aktas H, Lenz P, Meister T, Luegering A, Ullerich H, Aabakken L, Heinecke A, Domschke W, Kuipers E, Bretthauer M. Single- vs. double-balloon enteroscopy in small-bowel diagnostics: a randomized multicenter trial. Endoscopy. 2011 Jun;43(6):472-6. doi: 10.1055/s-0030-1256247. Epub 2011 Mar 7.

    PMID: 21384320BACKGROUND

  • Efthymiou M, Desmond PV, Brown G, La Nauze R, Kaffes A, Chua TJ, Taylor AC. SINGLE-01: a randomized, controlled trial comparing the efficacy and depth of insertion of single- and double-balloon enteroscopy by using a novel method to determine insertion depth. Gastrointest Endosc. 2012 Nov;76(5):972-80. doi: 10.1016/j.gie.2012.06.033. Epub 2012 Sep 12.

    PMID: 22980289BACKGROUND

  • May A, Farber M, Aschmoneit I, Pohl J, Manner H, Lotterer E, Moschler O, Kunz J, Gossner L, Monkemuller K, Ell C. Prospective multicenter trial comparing push-and-pull enteroscopy with the single- and double-balloon techniques in patients with small-bowel disorders. Am J Gastroenterol. 2010 Mar;105(3):575-81. doi: 10.1038/ajg.2009.712. Epub 2010 Jan 5.

    PMID: 20051942BACKGROUND

  • Takano N, Yamada A, Watabe H, Togo G, Yamaji Y, Yoshida H, Kawabe T, Omata M, Koike K. Single-balloon versus double-balloon endoscopy for achieving total enteroscopy: a randomized, controlled trial. Gastrointest Endosc. 2011 Apr;73(4):734-9. doi: 10.1016/j.gie.2010.10.047. Epub 2011 Jan 26.

    PMID: 21272875BACKGROUND

  • Yamamoto H, Kita H. Enteroscopy. J Gastroenterol. 2005 Jun;40(6):555-62. doi: 10.1007/s00535-005-1645-5.

    PMID: 16007388BACKGROUND

  • Archer M, Liu E, McDonald C, Yan B, Jairath V, Sey M. A randomized controlled trial of a through-the-scope stiffening wire to increase the depth of insertion during double-balloon enteroscopy. Gastrointest Endosc. 2025 Jun;101(6):1197-1200. doi: 10.1016/j.gie.2024.11.037. Epub 2024 Nov 26.

    PMID: 39608590DERIVED

Study Officials

  • Michael Sey, MD

    London Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2016

First Posted

March 28, 2016

Study Start

July 1, 2016

Primary Completion

December 28, 2022

Study Completion

January 5, 2023

Last Updated

October 5, 2023

Record last verified: 2023-10

Locations

CA(1)