Trial Outcomes & Findings for Gastric Outlet Obstructions Tailored Covered Stents for GOO (NCT NCT02299258)
NCT ID: NCT02299258
Last Updated: 2015-02-12
Results Overview
number of participants considered having efficacious outcome. Efficacy is defined by Ingrowth + overgrowth in this study
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
63 participants
Primary outcome timeframe
up to 5 years
Results posted on
2015-02-12
Participant Flow
Participant milestones
| Measure |
Tailored Stents MTN-WE-20/100-A
The distal portion of the GOO tailored stents was semi-spherical, with a length of 20 mm, and a diameter of 28 mm. The middle segment had a diameter of 20 mm. The overall length of the stents was 100 mm. Both the middle part and the bottom of the proximal cup segment, and a part of the proximal funnel segment, were covered by a polyethylene membrane.
Tailored stents MTN-WE-20/100-A: cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs.
|
Standard Stents MTN-CG-s-20/100
Standard uncovered stents were used in the control group. The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm
Standard stents MTN-CG-s-20/100: The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
31
|
|
Overall Study
COMPLETED
|
31
|
30
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gastric Outlet Obstructions Tailored Covered Stents for GOO
Baseline characteristics by cohort
| Measure |
Tailored Stents MTN-WE-20/100-A
n=32 Participants
The distal portion of the GOO tailored stents was semi-spherical, with a length of 20 mm, and a diameter of 28 mm. The middle segment had a diameter of 20 mm. The overall length of the stents was 100 mm. Both the middle part and the bottom of the proximal cup segment, and a part of the proximal funnel segment, were covered by a polyethylene membrane.
Tailored stents MTN-WE-20/100-A: cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs.
|
Standard Stents MTN-CG-s-20/100
n=31 Participants
Standard uncovered stents were used in the control group. The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm
Standard stents MTN-CG-s-20/100: The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
76.4 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
75.8 years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
76.1 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
32 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
32 participants
n=5 Participants
|
31 participants
n=7 Participants
|
63 participants
n=5 Participants
|
|
Gastric outlet obstruction score
|
3.2 units on a scale
n=5 Participants
|
3.1 units on a scale
n=7 Participants
|
3.2 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 5 yearsnumber of participants considered having efficacious outcome. Efficacy is defined by Ingrowth + overgrowth in this study
Outcome measures
| Measure |
Tailored Stents MTN-WE-20/100-A
n=32 Participants
The distal portion of the GOO tailored stents was semi-spherical, with a length of 20 mm, and a diameter of 28 mm. The middle segment had a diameter of 20 mm. The overall length of the stents was 100 mm. Both the middle part and the bottom of the proximal cup segment, and a part of the proximal funnel segment, were covered by a polyethylene membrane.
Tailored stents MTN-WE-20/100-A: cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs.
|
Standard Stents MTN-CG-s-20/100
n=31 Participants
Standard uncovered stents were used in the control group. The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm
Standard stents MTN-CG-s-20/100: The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm
|
|---|---|---|
|
Efficiency of Stents
|
1 participants
|
7 participants
|
SECONDARY outcome
Timeframe: up to 5 yearsbleeding, abdominal pain
Outcome measures
| Measure |
Tailored Stents MTN-WE-20/100-A
n=32 Participants
The distal portion of the GOO tailored stents was semi-spherical, with a length of 20 mm, and a diameter of 28 mm. The middle segment had a diameter of 20 mm. The overall length of the stents was 100 mm. Both the middle part and the bottom of the proximal cup segment, and a part of the proximal funnel segment, were covered by a polyethylene membrane.
Tailored stents MTN-WE-20/100-A: cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs.
|
Standard Stents MTN-CG-s-20/100
n=31 Participants
Standard uncovered stents were used in the control group. The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm
Standard stents MTN-CG-s-20/100: The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm
|
|---|---|---|
|
Adverse Events
|
25 participants
|
4 participants
|
Adverse Events
Tailored Stents MTN-WE-20/100-A
Serious events: 25 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Stents MTN-CG-s-20/100
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tailored Stents MTN-WE-20/100-A
n=32 participants at risk
The distal portion of the GOO tailored stents was semi-spherical, with a length of 20 mm, and a diameter of 28 mm. The middle segment had a diameter of 20 mm. The overall length of the stents was 100 mm. Both the middle part and the bottom of the proximal cup segment, and a part of the proximal funnel segment, were covered by a polyethylene membrane.
Tailored stents MTN-WE-20/100-A: cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs.
|
Standard Stents MTN-CG-s-20/100
n=31 participants at risk
Standard uncovered stents were used in the control group. The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm
Standard stents MTN-CG-s-20/100: The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm
|
|---|---|---|
|
Blood and lymphatic system disorders
Bleeding
|
34.4%
11/32 • Number of events 11
|
6.5%
2/31 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
40.6%
13/32 • Number of events 13
|
3.2%
1/31 • Number of events 1
|
|
Gastrointestinal disorders
Food impaction
|
3.1%
1/32 • Number of events 1
|
3.2%
1/31 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Dr.Ding Shi
The First People's Hospital of Yuhang District
Phone: +8657189369162
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place