Small Bowel Disease
Conditions
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.
Interventions
DEVICEDeep enteroscopy
A deep enteroscopy conducted with the new medical device PowerSpiral.
Sponsors
Olympus Europe SE & Co. KG
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Collect Serious Adverse Events and Device Deficiencies to Demonstrate Safety of the Motorized Spiral Endoscope (PowerSpiral) in Daily Medical Practice. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Therapeutic Yield | up to 12 days | Defined as the percentage of patients with any endoscopic intervention / therapy with the exception of biopsies. |
| Number of Participants With Procedures That Confirmed Previous Diagnosis | 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. |
Countries
Belgium, Denmark, Finland, France, Germany, Norway
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Arm Patients who received at least one procedure with the Motorized Spiral Endoscope (PowerSpiral). | 298 |
| Total | 298 |
Baseline characteristics
| Characteristic | Single Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 176 Participants |
| Age, Categorical Between 18 and 65 years | 122 Participants |
| Age, Continuous | 68 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 298 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 120 Participants |
| Sex: Female, Male Male | 178 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 298 |
| other Total, other adverse events | 9 / 298 |
| serious Total, serious adverse events | 7 / 298 |
Outcome results
Primary
Collect Serious Adverse Events and Device Deficiencies to Demonstrate Safety of the Motorized Spiral Endoscope (PowerSpiral) in Daily Medical Practice.
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
Time frame: up to 12 days
Population: SAE rate
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single Arm | Collect Serious Adverse Events and Device Deficiencies to Demonstrate Safety of the Motorized Spiral Endoscope (PowerSpiral) in Daily Medical Practice. | Serious Adverse Events | 6 participants |
| Single Arm | Collect Serious Adverse Events and Device Deficiencies to Demonstrate Safety of the Motorized Spiral Endoscope (PowerSpiral) in Daily Medical Practice. | Device Deficiencies | 1 participants |
Secondary
Number of Participants With Procedures That Confirmed Previous Diagnosis
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.
Time frame: up to 12 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm | Number of Participants With Procedures That Confirmed Previous Diagnosis | 251 Participants |
Secondary
Number of Participants With Therapeutic Yield
Defined as the percentage of patients with any endoscopic intervention / therapy with the exception of biopsies.
Time frame: up to 12 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm | Number of Participants With Therapeutic Yield | 172 Participants |