Total Motorized Spiral Enteroscopy Trial (TMSET)

February 13, 2018 updated by: Evangelisches Krankenhaus Düsseldorf

Study design Prospective bicentric non-controlled clinical trial

Study purpose

- to evaluate the efficacy and safety of Novel Motorized Spiral Enteroscopy (NMSE) for total enteroscopy in patients with suspected small bowel diseases with an indication for direct visualization of the entire small bowel

Primary objective

Rate of total enteroscopy by means of NMSE with:

  1. a complete anterograde approach
  2. or a combined anterograde and retrograde approach

Secondary objectives

  • Procedural success of anterograde and retrograde approach
  • Procedural time (minutes)
  • Depth of maximum insertion (cm)
  • Diagnostic yield
  • Therapeutic yield
  • Adverse events

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

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

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with small bowel disease with an indication for a total enteroscopy, e.g.:
  • Overt obscure gastrointestinal bleeding or obscure gastrointestinal bleeding or indeterminate iron-deficiency anaemia and positive Video capsule endoscopy (VCE) or negative VCE in patients who have ongoing bleeding shown by overt bleeding or continued need for blood transfusions
  • Abdominal pain or chronic diarrhoea with positive findings of small bowel imaging examinations
  • Noncontributory ileocolonoscopy and suspicion of Crohn's disease on small-bowel cross-sectional imaging modalities or small-bowel capsule endoscopy
  • Further evaluation of known Crohn's disease or therapeutic indications in Crohn's disease
  • Large polyps (>10-15mm) in the jejunum and ileum discovered by radiological examination or small-bowel capsule endoscopy in patients with Peutz-Jeghers syndrome
  • Nonresponsive or refractory coeliac disease

Exclusion Criteria:

  • - Age under 18 years
  • Health status American Society of Anesthesists Classification (ASA) 4
  • Pregnancy
  • Coagulopathy (INR≥2.0, Platelets < 70/nl)
  • Taking anti-platelet agents or anticoagulants (other than aspirin) within last 7 days
  • Any medical contraindication to standard enteroscopy
  • Presence of any intraluminal or extraluminal 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 stenosis or history of bowel obstruction
  • Known coagulation disorder
  • Known or suspected esophageal stricture or Schatzki ring
  • Known gastric or esophageal varices
  • Suspected perforation of the GI tract
  • Known or suspected colonic or ileocecal valve (ICV) stricture
  • Inability to tolerate sedation or general anesthesia for any reason
  • Inability to tolerate endotracheal intubation
  • Absence of a signed informed consent

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Motorized Spiral Enteroscopy
Patients with indication for total enteroscopy. day1: anterograde motorized spiral enteroscopy, day 2: retrograde motorized spiral enteroscopy
Procedure: Motorized Spiral Enteroscopy
Motorized Spiral endoscope will be inserted and advanced with the assistance of motorized clockwise spiral rotation, After reaching the cecum or if no further advancement of the endoscope can be achieved depth of insertion required for patient treatment or diagnosis, the endoscope will be withdrawn using motorized counter-clockwise spiral rotation, also controlled by the foot pedal. If no total enteroscopy was achieved, a submucosal ink dye injection is performed as an endoscopically visible marker of the maximum insertion depth. A retrograde peranal enteroscopy is then performed on one of the following days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of total enteroscopy by Motorized Spiral Enteroscopy
Time Frame: 2 days

Total enteroscopy by:

  1. a complete anterograde approach
  2. or a combined anterograde and retrograde approach
2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedural Success Rate
Time Frame: 2 days
of anterograde and retrograde approach
2 days
Procedural time
Time Frame: 2 days
of anterograde and retrograde approach
2 days
Depth of maximum insertion to the small bowel
Time Frame: 2 days
anterograde and retrograde
2 days
Diagnostic yield
Time Frame: 2 days
anterograde and retrograde
2 days
Therapeutic yield
Time Frame: 2 days
anterograde and retrograde
2 days
Adverse events
Time Frame: 3 days
anterograde and retrograde, serious adverse events
3 days

Collaborators and Investigators

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

Sponsor

Evangelisches Krankenhaus Düsseldorf

Collaborators

Université Libre de Bruxelles

Investigators

  • Study Chair: Torsten Beyna, MD, EVK Düsseldorf, Germany

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 (Anticipated)

February 21, 2018

Primary Completion (Anticipated)

February 21, 2019

Study Completion (Anticipated)

February 28, 2019

Study Registration Dates

First Submitted

February 13, 2018

First Submitted That Met QC Criteria

February 13, 2018

First Posted (Actual)

February 20, 2018

Study Record Updates

Last Update Posted (Actual)

February 20, 2018

Last Update Submitted That Met QC Criteria

February 13, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMSET 1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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