NCT04884113

Brief Summary

Multicenter study to evaluate the efficacy of the motorized spiral enteroscope in the management of small bowel diseases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

5 active sites

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

Study Start

First participant enrolled

March 1, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 12, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

April 26, 2023

Status Verified

April 1, 2023

Enrollment Period

1.8 years

First QC Date

May 3, 2021

Last Update Submit

April 24, 2023

Conditions

Small Bowel Disease

Keywords

Motorized Spiral enteroscopyDevice-assisted enteroscopy

Outcome Measures

Primary Outcomes (2)

  • The diagnostic yield of motorized spiral enteroscopy

    Diagnostic yield achieved by antegrade and/or retrograde enteroscopy using motorized spiral enteroscopy

    2 days

  • The therapeutic yield of motorized spiral enteroscopy

    Total number of therapeutic interventions performed during antegrade and/or retrograde enteroscopy using the motorized spiral enteroscopy

    2 days

Secondary Outcomes (5)

  • Total enteroscopy rate

    2 days

  • Technical success

    2 days

  • Total procedural time

    2 days

  • Depth of maximum insertion into the small bowel

    2 days

  • Adverse events

    7 days

Study Arms (1)

Experimental: Motorized Spiral Enteroscopy

Procedure: Motorized Spiral Enteroscopy: PowerSpiral enteroscope will be inserted and advanced with the assistance of motorized spiral rotation, After reaching the point of maximum insertion, cecum or if no further advancement of the enteroscope can be achieved, the enteroscope will be withdrawn using motorized counter-clockwise spiral rotation. When no total enteroscopy is reached, submucosal ink dye injection is performed as an endoscopically visible marker of the maximum insertion depth. A retrograde enteroscopy is then performed in the same session or at second session

Device: Motorized Spiral enteroscopy

Interventions

Motorized Spiral enteroscopyDEVICE

Small-bowel enteroscopy for diagnosis and intervention

Experimental: Motorized Spiral Enteroscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with suspected small bowel pathology indicated for diagnostic and/or therapeutic enteroscopy based on clinical presentation, small bowel imaging, or video capsule enteroscopy

You may qualify if:

  • Age 18 years and older
  • Patients with suspected small bowel pathology indicated for diagnostic and/or therapeutic enteroscopy based on clinical presentation, small bowel imaging, or video capsule enteroscopy
  • Written informed consent

You may not qualify if:

  • Contraindications for endoscopy because of comorbidities
  • Unable to provide written informed consent
  • Patients with known severe gastrointestinal tract inflammation, intestinal obstruction, gastroesophageal varices or eosinophilic esophagitis that preclude a safe enteroscopy procedure
  • Coagulopathy or thrombocytopenia that could not be corrected by blood product transfusion
  • Pregnant patients
  • Health status: American Society of Anesthesiologists (ASA) class \>3
  • Inability to tolerate Propofol sedation or general anesthesia for any reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

VU University Medical Center

Amsterdam, 6813KJ, Netherlands

Location

University Medical Centre Groningen

Groningen, 9700 RB, Netherlands

Location

Leiden University Medical Centre

Leiden, 2311ZN, Netherlands

Location

Maastricht UMC+

Maastricht, 6202 AZ, Netherlands

Location

St Antonius hospital

Utrecht, 3430 EM, Netherlands

Location

Related Publications (1)

  • Al-Toma A, Beaumont H, Koornstra JJ, van Boeckel P, Hergelink DO, van der Kraan J, Inderson A, de Ridder R, Jacobs M. The performance and safety of motorized spiral enteroscopy, including in patients with surgically altered gastrointestinal anatomy: a multicenter prospective study. Endoscopy. 2022 Nov;54(11):1034-1042. doi: 10.1055/a-1783-4802. Epub 2022 Feb 28.

    PMID: 35226945DERIVED

Study Officials

  • A Al-Toma, Ph.D.

    St. Antonius Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 3, 2021

First Posted

May 12, 2021

Study Start

March 1, 2020

Primary Completion

December 30, 2021

Study Completion

March 1, 2022

Last Updated

April 26, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

NL(5)