A Clinical Study With the Medical Device PowerSpiral for Deep Enteroscopy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

302 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-02

Study Completion Date

2021-05-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Small Bowel Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Deep enteroscopy

A deep enteroscopy conducted with the new medical device PowerSpiral.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No