PowerSpiral Enteroscopy Performance and Safety

April 24, 2023 updated by: Abdulbaqi Al-Toma, St. Antonius Hospital

PowerSpiral Enteroscopy: Multicenter Prospective Study on Performance and Safety Including Patients With Altered Gastrointestinal Anatomy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background and Aims:

Motorized Spiral enteroscopy is a recent advancement in enteroscopy. Data are scarce on the utility and safety of the motorized spiral enteroscopy. No data is available on the utility of this technique in patients with altered gastrointestinal (GI) anatomy.

This study aimed to evaluate the efficacy of motorized spiral enteroscopy including rate of total enteroscopy (TER) in patients undergoing enteroscopy for suspected small bowel disease including those with altered GI anatomy.

Methods: A multicenter prospective study evaluated consecutive patients with symptomatic small bowel disease who underwent enteroscopy over a 12-month period.

Study Type

Observational

Enrollment (Actual)

170

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 6813KJ
        • VU University Medical Center
      • Groningen, Netherlands, 9700 RB
        • University Medical Centre Groningen
      • Leiden, Netherlands, 2311ZN
        • Leiden University Medical Centre
      • Maastricht, Netherlands, 6202 AZ
        • Maastricht UMC+
      • Utrecht, Netherlands, 3430 EM
        • St Antonius Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Small-bowel enteroscopy for diagnosis and intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The diagnostic yield of motorized spiral enteroscopy
Time Frame: 2 days
Diagnostic yield achieved by antegrade and/or retrograde enteroscopy using motorized spiral enteroscopy
2 days
The therapeutic yield of motorized spiral enteroscopy
Time Frame: 2 days
Total number of therapeutic interventions performed during antegrade and/or retrograde enteroscopy using the motorized spiral enteroscopy
2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total enteroscopy rate
Time Frame: 2 days
Estimate the number of total enteroscopy procedures achieved by either antegrade only or antegrade and retrograde motorized spiral enteroscopy
2 days
Technical success
Time Frame: 2 days
Estimate the rate of technically successful enteroscopy procedures both antegrade and retrograde motorized spiral enteroscopy
2 days
Total procedural time
Time Frame: 2 days
The total time needed to complete the whole procedure of enteroscopy antegrade and/or retrograde motorized spiral enteroscopy
2 days
Depth of maximum insertion into the small bowel
Time Frame: 2 days
Estimation of the maximum depth of insertion (in centimeters) both antegrade and/or retrograde motorized spiral enteroscopy
2 days
Adverse events
Time Frame: 7 days
Total minor and also serious adverse events during and after antegrade and/or retrograde motorized spiral enteroscopy
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Antonius Hospital

Investigators

  • Principal Investigator: A Al-Toma, Ph.D., St. Antonius Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Actual)

December 30, 2021

Study Completion (Actual)

March 1, 2022

Study Registration Dates

First Submitted

May 3, 2021

First Submitted That Met QC Criteria

May 6, 2021

First Posted (Actual)

May 12, 2021

Study Record Updates

Last Update Posted (Actual)

April 26, 2023

Last Update Submitted That Met QC Criteria

April 24, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • W20.204

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Small Bowel Disease

Clinical Trials on Motorized Spiral enteroscopy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe