European Novel Motorized Spiral Endoscopy Trial (ENMSET)

February 13, 2018 updated by: Torsten Beyna, Evangelisches Krankenhaus Düsseldorf
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

General anesthesia and/or sedation will be prescribed according to institutional practices and clinical judgment; type, amount and duration will be recorded.

A standard esophagogastroduodenoscopy (EGD) will be performed prior to the enteroscopy. If during this preliminary exam the endoscopist identifies any stricture or believes the patient has anatomy that would cause excessive resistance during Novel Motorized Spiral insertion or examination, the patient will be withdrawn from the study and the reason for study withdrawal will be noted.

The Novel Motorized Spiral endoscope will be inserted and advanced with the assistance of motorized clockwise spiral rotation, (controlled directly by the operating physician via the foot pedal). If at any point a stricture is observed or excessive resistance to the advancement of the endoscope is encountered, further advancement of the endoscope must cease and the reason for procedure termination documented on the case report form.

After reaching the 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. Maximum depth of insertion will be recorded as the maximum insertion depth when failure to advance the endoscope tip after repositioning the patient, applying abdominal pressure and/or using other standard measures fails to advance the endoscope OR the investigator decides to terminate advancement based on clinical judgment. During withdrawal, the endoscopist will cumulatively estimate the length of bowel released from the endoscope tip in order to calculate the total depth of insertion. Insertion depth will be referenced to the Ligament Treitz. If the clinician decides to mark the point of maximum insertion, the tissue may be tattooed by first creating a saline bleb, followed by the injection of India ink (e.g., SPOT).

Tissue sampling and/or therapies will be performed during withdrawal as clinically appropriate. The details of all sampling and/or therapies (number, type & location) will be recorded.

The comfort and cardiopulmonary stability of the patient will be monitored throughout the procedure, as per the standard of care - this includes continuous pulse oximetry, blood pressure, and heart rate monitoring.

Photographs or video recordings are used to document any significant lesions and any tissue trauma.

Postprocedural measures Patients will be hospitalized for at least 24 hours after NMSE because of the potential risk of delayed adverse events. Only liquid diet is allowed during the first 12 hours in asymptomatic patients. Clinical investigation and determination of the blood cell count and the serum level of C-reactive protein will be done after 24 hours. 30 days after the procedure patients will be interviewed by a telephone call for evaluation of complaints or delayed complications. Discomfort (location and severity (0-10 VAS) should be documented immediately after NMSE, after 24 hours and before discharge.

Study Type

Interventional

Enrollment (Actual)

136

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.

Study Locations

  • Belgium
      • Brussels, Belgium
        • Universite Libre des Bruxelles
  • Germany
      • Duesseldorf, Germany, 40217
        • Evangelisches Krankenhaus

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:

  • 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

Exclusion Criteria:

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: motorized spiral enteroscopy
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
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.
Other Names:
  • standard endoscopic interventions (not experimental)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diagnostic yield of NMSE in patients with suspected small bowel diseases
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Procedural success
Time Frame: 30 days
30 days
Procedural time (minutes)
Time Frame: 30 days
30 days
Depth of maximal insertion (cm)
Time Frame: 30 days
30 days
Therapeutic yield
Time Frame: 30 days
30 days
Adverse events
Time Frame: 30 days
30 days

Collaborators and Investigators

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

Sponsor

Evangelisches Krankenhaus Düsseldorf

Collaborators

Olympus

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

November 1, 2015

Primary Completion (Actual)

February 3, 2018

Study Completion (Actual)

February 6, 2018

Study Registration Dates

First Submitted

November 11, 2016

First Submitted That Met QC Criteria

November 11, 2016

First Posted (Estimate)

November 16, 2016

Study Record Updates

Last Update Posted (Actual)

February 14, 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

  • ENMSET

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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