Trial Outcomes & Findings for A Clinical Study With the Medical Device PowerSpiral for Deep Enteroscopy (NCT NCT03955081)
NCT ID: NCT03955081
Last Updated: 2024-01-30
Results Overview
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
Recruitment status
COMPLETED
Target enrollment
302 participants
Primary outcome timeframe
up to 12 days
Results posted on
2024-01-30
Participant Flow
Participant milestones
| Measure |
Single Arm
Patients who received at least one procedure with the Motorized Spiral Endoscope (PowerSpiral).
|
|---|---|
|
Overall Study
STARTED
|
302
|
|
Overall Study
COMPLETED
|
302
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Study With the Medical Device PowerSpiral for Deep Enteroscopy
Baseline characteristics by cohort
| Measure |
Single Arm
n=298 Participants
Patients who received at least one procedure with the Motorized Spiral Endoscope (PowerSpiral).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
122 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
176 Participants
n=5 Participants
|
|
Age, Continuous
|
68 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
120 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
178 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
298 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 12 daysPopulation: SAE rate
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
Outcome measures
| Measure |
Single Arm
n=298 Participants
Patients who received at least one procedure with the Motorized Spiral Endoscope (PowerSpiral).
|
|---|---|
|
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
|
|
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 outcome
Timeframe: up to 12 daysDefined as the percentage of patients with any endoscopic intervention / therapy with the exception of biopsies.
Outcome measures
| Measure |
Single Arm
n=298 Participants
Patients who received at least one procedure with the Motorized Spiral Endoscope (PowerSpiral).
|
|---|---|
|
Number of Participants With Therapeutic Yield
|
172 Participants
|
SECONDARY outcome
Timeframe: up to 12 daysDefined 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.
Outcome measures
| Measure |
Single Arm
n=298 Participants
Patients who received at least one procedure with the Motorized Spiral Endoscope (PowerSpiral).
|
|---|---|
|
Number of Participants With Procedures That Confirmed Previous Diagnosis
|
251 Participants
|
Adverse Events
Single Arm
Serious events: 7 serious events
Other events: 9 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Single Arm
n=298 participants at risk
Patients who received at least one procedure with the Motorized Spiral Endoscope (PowerSpiral).
|
|---|---|
|
Gastrointestinal disorders
Perforation
|
0.67%
2/298 • Number of events 2 • Adverse events were collected during the whole study duration of approx. 18 months and for each individual patients from signing the consent until hospital discharge.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Gastrointestinal disorders
Bleeding
|
0.67%
2/298 • Number of events 2 • Adverse events were collected during the whole study duration of approx. 18 months and for each individual patients from signing the consent until hospital discharge.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Gastrointestinal disorders
Mucosal injury
|
0.34%
1/298 • Number of events 1 • Adverse events were collected during the whole study duration of approx. 18 months and for each individual patients from signing the consent until hospital discharge.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
General disorders
Complications associated with sedation/anesthesia
|
0.34%
1/298 • Number of events 1 • Adverse events were collected during the whole study duration of approx. 18 months and for each individual patients from signing the consent until hospital discharge.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Gastrointestinal disorders
Other
|
0.34%
1/298 • Number of events 1 • Adverse events were collected during the whole study duration of approx. 18 months and for each individual patients from signing the consent until hospital discharge.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
Other adverse events
| Measure |
Single Arm
n=298 participants at risk
Patients who received at least one procedure with the Motorized Spiral Endoscope (PowerSpiral).
|
|---|---|
|
Gastrointestinal disorders
Bleeding
|
3.0%
9/298 • Number of events 9 • Adverse events were collected during the whole study duration of approx. 18 months and for each individual patients from signing the consent until hospital discharge.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Gastrointestinal disorders
Laceration
|
1.3%
4/298 • Number of events 4 • Adverse events were collected during the whole study duration of approx. 18 months and for each individual patients from signing the consent until hospital discharge.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place