Trial Outcomes & Findings for Assessment of Gastric Volume Reduction in Surgical Weight Loss Candidates (NCT NCT00721227)
NCT ID: NCT00721227
Last Updated: 2010-09-08
Results Overview
The number of participants who completed the study and had post-opeartive gastrocopies showing intact plications.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
Immediately post-operative
Results posted on
2010-09-08
Participant Flow
Enrollment period started April 17, 2008. Enrollment continued until December 31, 2008. The followup period continued until January 29, 2010. Enrollment was conducted in the bariatric and research offices of The Cleveland Clinic Foundation, Cleveland, Ohio.
Participant milestones
| Measure |
Anterior Curve
Reduction Gastroplasty by Gastric Plication on Anterior Curve
|
Greater Curve
Reduction Gastroplasty by Gastric Plication on Greater Curve
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
6
|
|
Overall Study
COMPLETED
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
Anterior Curve
Reduction Gastroplasty by Gastric Plication on Anterior Curve
|
Greater Curve
Reduction Gastroplasty by Gastric Plication on Greater Curve
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
|
Overall Study
Noncompliance with scheduled visits.
|
1
|
0
|
Baseline Characteristics
Assessment of Gastric Volume Reduction in Surgical Weight Loss Candidates
Baseline characteristics by cohort
| Measure |
Anterior Curve
n=9 Participants
Reduction Gastroplasty by Gastric Plication on Anterior Curve
|
Greater Curve
n=6 Participants
Reduction Gastroplasty by Gastric Plication on Greater Curve
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
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
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
45.0 years
STANDARD_DEVIATION 10.37 • n=5 Participants
|
36.8 years
STANDARD_DEVIATION 8.42 • n=7 Participants
|
41.7 years
STANDARD_DEVIATION 10.19 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
6 participants
n=7 Participants
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Immediately post-operativeThe number of participants who completed the study and had post-opeartive gastrocopies showing intact plications.
Outcome measures
| Measure |
Anterior Curve
n=9 Participants
Reduction Gastroplasty by Gastric Plication on Anterior Curve
|
Greater Curve
n=6 Participants
Reduction Gastroplasty by Gastric Plication on Greater Curve
|
|---|---|---|
|
Successful Gastric Plication Using Reduction Gastroplasty
|
9 participants
|
6 participants
|
SECONDARY outcome
Timeframe: 12 monthPopulation: Includes only participants who completed month 12 gastroscopy.
The number of participants who completed month 12 gastroscopies showing intact plications.
Outcome measures
| Measure |
Anterior Curve
n=5 Participants
Reduction Gastroplasty by Gastric Plication on Anterior Curve
|
Greater Curve
n=6 Participants
Reduction Gastroplasty by Gastric Plication on Greater Curve
|
|---|---|---|
|
Durability of Gastric Plications Following Reduction Gastroplasty
|
4 participants
|
5 participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Includes only participants who completed month 12 visit.
Percentage of excess weight loss calculated at 12 months post-surgery. Percentage of excess weight loss is calculated is the difference in baseline and post-surgery weight divided by the difference in baseline weight and ideal body weight multiplied by 100.
Outcome measures
| Measure |
Anterior Curve
n=5 Participants
Reduction Gastroplasty by Gastric Plication on Anterior Curve
|
Greater Curve
n=6 Participants
Reduction Gastroplasty by Gastric Plication on Greater Curve
|
|---|---|---|
|
Weight Loss Following Reduction Gastroplasty
|
23.30 Percentage of weight loss
Standard Deviation 24.88
|
53.43 Percentage of weight loss
Standard Deviation 22.67
|
Adverse Events
Anterior Curve
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Greater Curve
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Anterior Curve
n=9 participants at risk
Reduction Gastroplasty by Gastric Plication on Anterior Curve
|
Greater Curve
n=6 participants at risk
Reduction Gastroplasty by Gastric Plication on Greater Curve
|
|---|---|---|
|
Hepatobiliary disorders
Acute Cholecystitis
|
0.00%
0/9 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
16.7%
1/6 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Gastrointestinal disorders
Ecessive Post Operative Vomiting
|
0.00%
0/9 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
16.7%
1/6 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
Other adverse events
| Measure |
Anterior Curve
n=9 participants at risk
Reduction Gastroplasty by Gastric Plication on Anterior Curve
|
Greater Curve
n=6 participants at risk
Reduction Gastroplasty by Gastric Plication on Greater Curve
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
55.6%
5/9 • Number of events 5 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
100.0%
6/6 • Number of events 10 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
11.1%
1/9 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
0.00%
0/6 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Gastrointestinal disorders
Abdominal distension
|
11.1%
1/9 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
0.00%
0/6 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Gastrointestinal disorders
Constipation
|
22.2%
2/9 • Number of events 2 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
50.0%
3/6 • Number of events 3 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Gastrointestinal disorders
Dental caries
|
11.1%
1/9 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
0.00%
0/6 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
1/9 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
0.00%
0/6 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Gastrointestinal disorders
Gastric ulcer
|
11.1%
1/9 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
0.00%
0/6 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Cardiac disorders
Tachycardia
|
11.1%
1/9 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
0.00%
0/6 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
33.3%
2/6 • Number of events 2 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Skin and subcutaneous tissue disorders
alopecia
|
11.1%
1/9 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
16.7%
1/6 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Injury, poisoning and procedural complications
ankle fracture
|
11.1%
1/9 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
0.00%
0/6 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Psychiatric disorders
anxiety
|
0.00%
0/9 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
16.7%
1/6 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
0.00%
0/9 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
16.7%
1/6 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Musculoskeletal and connective tissue disorders
back pain
|
11.1%
1/9 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
16.7%
1/6 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Investigations
blood glucose increased
|
11.1%
1/9 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
0.00%
0/6 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Investigations
blood magnesium decreased
|
0.00%
0/9 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
16.7%
1/6 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Respiratory, thoracic and mediastinal disorders
bronchospasm
|
11.1%
1/9 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
0.00%
0/6 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Injury, poisoning and procedural complications
burns first degree
|
0.00%
0/9 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
16.7%
1/6 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
General disorders
chest discomfort
|
11.1%
1/9 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
0.00%
0/6 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Psychiatric disorders
depression
|
0.00%
0/9 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
16.7%
1/6 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Skin and subcutaneous tissue disorders
dermal cyst
|
0.00%
0/9 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
16.7%
1/6 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
General disorders
early satiety
|
11.1%
1/9 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
0.00%
0/6 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
General disorders
fatigue
|
0.00%
0/9 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
16.7%
1/6 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Metabolism and nutrition disorders
fluid overload
|
0.00%
0/9 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
16.7%
1/6 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Nervous system disorders
headache
|
0.00%
0/9 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
16.7%
1/6 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Hepatobiliary disorders
hepatic steatosis
|
11.1%
1/9 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
0.00%
0/6 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Gastrointestinal disorders
hiatus hernia
|
11.1%
1/9 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
16.7%
1/6 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Vascular disorders
hypertension
|
33.3%
3/9 • Number of events 3 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
33.3%
2/6 • Number of events 2 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Metabolism and nutrition disorders
hypokalaemia
|
0.00%
0/9 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
16.7%
1/6 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Psychiatric disorders
insomnia
|
0.00%
0/9 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
16.7%
1/6 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Injury, poisoning and procedural complications
limb injury
|
11.1%
1/9 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
0.00%
0/6 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Reproductive system and breast disorders
menorrhagia
|
0.00%
0/9 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
16.7%
1/6 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal pain
|
0.00%
0/9 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
33.3%
2/6 • Number of events 3 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Respiratory, thoracic and mediastinal disorders
nasal septum deviation
|
11.1%
1/9 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
0.00%
0/6 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Respiratory, thoracic and mediastinal disorders
nasal turbinate hypertrophy
|
11.1%
1/9 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
0.00%
0/6 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Gastrointestinal disorders
nausea
|
77.8%
7/9 • Number of events 7 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
100.0%
6/6 • Number of events 7 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Renal and urinary disorders
nephrolithiasis
|
0.00%
0/9 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
16.7%
1/6 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
General disorders
oedema peripheral
|
0.00%
0/9 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
16.7%
1/6 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Infections and infestations
oral candidiasis
|
0.00%
0/9 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
16.7%
1/6 • Number of events 2 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
General disorders
pain
|
11.1%
1/9 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
0.00%
0/6 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
11.1%
1/9 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
0.00%
0/6 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Infections and infestations
pharyngitis
|
0.00%
0/9 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
16.7%
1/6 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Injury, poisoning and procedural complications
post procedural haematoma
|
11.1%
1/9 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
0.00%
0/6 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Injury, poisoning and procedural complications
procedural complication
|
0.00%
0/9 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
16.7%
1/6 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Injury, poisoning and procedural complications
procedural pain
|
33.3%
3/9 • Number of events 3 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
0.00%
0/6 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Injury, poisoning and procedural complications
procedural vomiting
|
0.00%
0/9 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
16.7%
1/6 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Congenital, familial and genetic disorders
prokeratosis
|
0.00%
0/9 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
16.7%
1/6 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Skin and subcutaneous tissue disorders
rash
|
11.1%
1/9 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
16.7%
1/6 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Musculoskeletal and connective tissue disorders
rotator cuff syndrome
|
11.1%
1/9 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
0.00%
0/6 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Infections and infestations
sinusitis
|
11.1%
1/9 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
16.7%
1/6 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
skin papilloma
|
0.00%
0/9 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
16.7%
1/6 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Infections and infestations
upper respiratory tract infection
|
0.00%
0/9 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
33.3%
2/6 • Number of events 3 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Infections and infestations
urinary tract infection
|
0.00%
0/9 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
16.7%
1/6 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Eye disorders
vision blurred
|
0.00%
0/9 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
16.7%
1/6 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/9 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
16.7%
1/6 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
|
Reproductive system and breast disorders
vulvovaginal pruritus
|
11.1%
1/9 • Number of events 1 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
0.00%
0/6 • 13 months
AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
|
Additional Information
Amy Mahanes, Senior Clinical Research Associate
Ethicon Endo Surgery, Inc.
Phone: 513-337-8366
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place