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A Clinical Study With the Medical Device PowerSpiral for Deep Enteroscopy (SAMISEN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03955081
Recruitment Status : Not yet recruiting
First Posted : May 17, 2019
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
Olympus Europe SE & Co. KG

Tracking Information
First Submitted Date February 1, 2019
First Posted Date May 17, 2019
Last Update Posted Date June 10, 2019
Estimated Study Start Date June 2019
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 16, 2019)
  • Collect Serious Adverse Events and Device Deficiencies to demonstrate safety of the Motorized Spiral Endoscope (PowerSpiral) in daily medical practice. [ Time Frame: up to 12 days ]
    It is assumed that the new device and its safety profile is non-inferior to preceding generations of balloon assisted enteroscopes. Endoscope (PowerSpiral) in a typical clinical setting within the Intended Use
  • Diagnostic Yield [ Time Frame: up to 12 days ]
    Defined as the percentage of procedures that either confirmed a diagnosis from previous studies, or established a new definitive diagnosis at the anatomical location identified in previous studies or findings that could explain the clinical symptoms.
  • Therapeutic Yield [ Time Frame: up to 12 days ]
    Defined as the percentage of patients with any endoscopic intervention / therapy with the exception of biopsies.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03955081 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Clinical Study With the Medical Device PowerSpiral for Deep Enteroscopy
Official Title Safety and Performance of the Motorized Spiral Endoscope (PowerSpiral) in Subjects Indicated for Small-bowel Enteroscopy: A PMCF Registry
Brief Summary The objective of the SAMISEN study is to assess the performance and safety of diagnostic and therapeutic procedures with the newly designed Olympus Motorized Spiral Enteroscope (PowerSpiral).
Detailed Description

The main objective of this registry is to collect data on the safety and performance of the new motorized PowerSpiral device during Post-market Clinical Follow-up. It is assumed that the new device and its safety profile is non-inferior to preceding generations of balloon assisted enteroscopes.

As clinical performance and efficacy is equally important for the user this study also collects efficacy and handling data of the new device.

Study Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration 5 Days
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects with an indication for direct visualization of the small bowel which fulfil all of these inclusion and exclusion criteria.
Condition Small Bowel Disease
Intervention Device: Deep enteroscopy
A deep enteroscopy conducted with the new medical device PowerSpiral.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: May 16, 2019)
335
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Signed informed consent
  2. Patients with small bowel disease indicated for deep enteroscopy

Exclusion Criteria:

  1. Age under 18 years
  2. Female and of child-bearing age who is currently pregnant or planning to become pregnant within the study period
  3. Any contraindication to standard enteroscopy
  4. Concurrent participation in another competing clinical study
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Peter Teichmann, PhD +49 40 23773-0 ext -7835 peter.teichmann@olympus-europa.com
Listed Location Countries Belgium,   Denmark,   Finland,   France,   Germany,   Italy,   Netherlands,   Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT03955081
Other Study ID Numbers 2018-GI (OEKG) - 01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Olympus Europe SE & Co. KG
Study Sponsor Olympus Europe SE & Co. KG
Collaborators Not Provided
Investigators
Principal Investigator: Torsten Beyna, MD Evangelisches Kranken-haus Düssel-dorf
PRS Account Olympus Europe SE & Co. KG
Verification Date May 2019