NCT02965209

Brief Summary

The subject Novel Motorized Spiral Enteroscope (NMSE) represents a new technology which offers all of the advantageous options of spiral enteroscopy with a faster and less invasive approach. The system is similar to other currently marketed endoscopes in that it incorporates a flexible insertion tube, light source, digital imaging, and channels for passing accessories for sample collection or therapeutic interventions. The NMSE system is unique in that it incorporates a user-controlled motor contained in the endoscope's handle to rotate a spiral cuff located on the endoscope's insertion tube. Rotation of this cuff, which has soft spiral-shaped "fins", pleats the small bowel on to the endoscope's insertion tube, thereby allowing rapid and atraumatic access deep into the small bowel. The system also includes a display monitor, a motor control unit, device to display measured motor current and signal torque, and a set of foot pedals. Motorization of the Spiral Enteroscope and limitation of rotation to a short cuff instead of a long overtube promise to accelerate the procedure, to facilitate insertion and to improve maneuvering the instrument in comparison to conventional spiral enteroscopy

Trial Health

90
On Track

Trial Health Score

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

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
2 countries

2 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

November 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 11, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 16, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2018

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2018

Completed
Last Updated

February 14, 2018

Status Verified

February 1, 2018

Enrollment Period

2.3 years

First QC Date

November 11, 2016

Last Update Submit

February 13, 2018

Conditions

Disorder of Small IntestineGastrointestinal HemorrhageIron Deficiency AnaemiaCrohn's DiseaseSmall Bowel TumorsIntestinal Polyposis SyndromeCoeliac Disease

Keywords

endoscopysmall bowel endoscopymotorized spiral endoscopyspiral endoscopy

Outcome Measures

Primary Outcomes (1)

  • Diagnostic yield of NMSE in patients with suspected small bowel diseases

    30 days

Secondary Outcomes (5)

  • Procedural success

    30 days

  • Procedural time (minutes)

    30 days

  • Depth of maximal insertion (cm)

    30 days

  • Therapeutic yield

    30 days

  • Adverse events

    30 days

Study Arms (1)

motorized spiral enteroscopy

EXPERIMENTAL

Novel Motorized Spiral Enteroscopy (NMSE) represents a new technology which offers all of the advantageous options of spiral enteroscopy with a faster and less invasive approach.

Procedure: motorized spiral enteroscopy

Interventions

motorized spiral enteroscopyPROCEDURE

Novel Motorized Spiral Enteroscopy (NMSE) represents a new technology which offers all of the advantageous options of spiral enteroscopy with a faster and less invasive approach. When the region of interest in the small bowel is reached by NMSE standard endoscopic techniques, e.g. argon plasma coagulation (APC), forceps biopsy or endoscopic mucosal resection (EMR) are performed for treatment and/or tissue acquisition.

Also known as: standard endoscopic interventions (not experimental)
motorized spiral enteroscopy

Eligibility Criteria

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

You may qualify if:

  • Overt obscure gastrointestinal bleeding or obscure gastrointestinal bleeding or indeterminate iron-deficiency anaemia and positive videocapsule 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
  • Imaging tests suspicious for small-bowel tumour
  • Large polyps (\>10-15mm) 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 Anesthesiologists 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
  • Inability to tolerate sedation or general anesthesia for any reason
  • Inability to tolerate endotracheal intubation
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universite Libre des Bruxelles

Brussels, Belgium

Location

Evangelisches Krankenhaus

Düsseldorf, 40217, Germany

Location

Related Publications (1)

  • Beyna T, Arvanitakis M, Schneider M, Gerges C, Boing D, Deviere J, Neuhaus H. Motorised spiral enteroscopy: first prospective clinical feasibility study. Gut. 2021 Feb;70(2):261-267. doi: 10.1136/gutjnl-2019-319908. Epub 2020 Apr 24.

    PMID: 32332141DERIVED

MeSH Terms

Conditions

Gastrointestinal HemorrhageAnemia, Iron-DeficiencyCrohn DiseaseCeliac Disease

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsAnemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesInflammatory Bowel DiseasesGastroenteritisIntestinal DiseasesMalabsorption Syndromes

Study Officials

  • Horst Neuhaus, MD

    Evangelisches Krankenhaus Duesseldorf

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 11, 2016

First Posted

November 16, 2016

Study Start

November 1, 2015

Primary Completion

February 3, 2018

Study Completion

February 6, 2018

Last Updated

February 14, 2018

Record last verified: 2018-02

Locations

DE(1)BE(1)