Total Motorized Spiral Enteroscopy Trial

NCT03438695 | Unknown DMC

• 1 other identifier: TMSET 1.0
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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:

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

Conditions

Small Bowel Disease

Keywords

endoscopy, motorized spiral enteroscopy

Outcome Measures

Primary Outcomes (1)

• Rate of total enteroscopy by Motorized Spiral Enteroscopy

  Total enteroscopy by: 1. a complete anterograde approach 2. or a combined anterograde and retrograde approach

  2 days

Secondary Outcomes (6)

• Procedural Success Rate

  2 days

• Procedural time

  2 days

• Depth of maximum insertion to the small bowel

  2 days

• Diagnostic yield

  2 days

• Therapeutic yield

  2 days

Study Arms (1)

Motorized Spiral Enteroscopy

EXPERIMENTAL

Patients with indication for total enteroscopy. day1: anterograde motorized spiral enteroscopy, day 2: retrograde motorized spiral enteroscopy

Procedure: Motorized Spiral Enteroscopy

Interventions

Motorized Spiral Enteroscopy PROCEDURE

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of the endoscope can be achieved depth of insertion required for patient treatment or diagnosis, the endoscope will be withdrawn using motorized counter-clockwise spiral rotation, also controlled by the foot pedal.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.

Motorized Spiral Enteroscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Evangelisches Krankenhaus Düsseldorf: lead
• Université Libre de Bruxelles: collaborator

Related Publications (1)

• Beyna T, Arvanitakis M, Schneider M, Gerges C, Hoellerich J, Deviere J, Neuhaus H. Total motorized spiral enteroscopy: first prospective clinical feasibility trial. Gastrointest Endosc. 2021 Jun;93(6):1362-1370. doi: 10.1016/j.gie.2020.10.028. Epub 2020 Nov 2.

  PMID: 33144239 DERIVED

Study Officials

• Torsten Beyna, MD

  EVK Düsseldorf, Germany

  STUDY CHAIR

Central Study Contacts

Torsten Beyna, MD

CONTACT

+49-211-9191605; torsten.beyna@evk-duesseldorf.de

Horst Neuhaus, MD, PhD

CONTACT

+49-211-9191605; horst.neuhaus@evk-duesseldorf.de

Study Design

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

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: February 20, 2018
• Study Start: February 21, 2018
• Primary Completion: February 21, 2019
• Study Completion: February 28, 2019
• Last Updated: February 20, 2018

Record last verified: 2018-02