Trial Outcomes & Findings for European Union (EU) Post-Market Study on Easyband® (NCT NCT00948246)
NCT ID: NCT00948246
Last Updated: 2014-10-13
Results Overview
Percent of subjects whose device implantation was rated by the surgeon as a 1 or 2 on a 5-point scale, where 1 is "very easy" and 5 is "impossible."
Recruitment status
COMPLETED
Target enrollment
112 participants
Primary outcome timeframe
< 1day
Results posted on
2014-10-13
Participant Flow
Participant milestones
| Measure |
Easyband
|
|---|---|
|
Overall Study
STARTED
|
110
|
|
Overall Study
COMPLETED
|
86
|
|
Overall Study
NOT COMPLETED
|
24
|
Reasons for withdrawal
| Measure |
Easyband
|
|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
|
Overall Study
Adverse Event
|
11
|
|
Overall Study
Death
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
European Union (EU) Post-Market Study on Easyband®
Baseline characteristics by cohort
| Measure |
Easyband
n=110 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
107 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
39.0 years
STANDARD_DEVIATION 11.23 • n=99 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=99 Participants
|
|
Region of Enrollment
Belgium
|
33 participants
n=99 Participants
|
|
Region of Enrollment
Netherlands
|
29 participants
n=99 Participants
|
|
Region of Enrollment
Italy
|
21 participants
n=99 Participants
|
|
Region of Enrollment
United Kingdom
|
27 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: < 1dayPopulation: Intent-to-treat
Percent of subjects whose device implantation was rated by the surgeon as a 1 or 2 on a 5-point scale, where 1 is "very easy" and 5 is "impossible."
Outcome measures
| Measure |
Easyband
n=110 Participants
|
|---|---|
|
Feasibility and Ease of Implantation
Introduction of Easyband into the abdomen
|
71.8 percentage of subjects
|
|
Feasibility and Ease of Implantation
Placing Easyband around the stomach
|
81.8 percentage of subjects
|
|
Feasibility and Ease of Implantation
Clipping of the Easyband around the stomach
|
88.2 percentage of subjects
|
SECONDARY outcome
Timeframe: 12 monthsPercent excess weight loss was defined as weight loss divided by excess weight multiplied by 100, where weight loss was equal to baseline weight minus follow-up weight, and excess weight was equal to baseline weight minus ideal weight.
Outcome measures
| Measure |
Easyband
n=110 Participants
|
|---|---|
|
% Excess Weight Loss
|
30.73 percentage of excess weight loss
Interval 29.389 to 35.128
|
SECONDARY outcome
Timeframe: 12 monthsDecrease in body mass index (BMI; measured in kg/m2) from baseline to 12 months
Outcome measures
| Measure |
Easyband
n=110 Participants
|
|---|---|
|
Change in BMI
|
-7.23 kg/m2
Interval -7.898 to 6.56
|
SECONDARY outcome
Timeframe: 12 monthsChange in weight (in kilograms) at baseline to 12 months
Outcome measures
| Measure |
Easyband
n=110 Participants
|
|---|---|
|
Change in Weight
|
-20.70 pounds
Interval -22.754 to 18.64
|
Adverse Events
Easyband
Serious events: 29 serious events
Other events: 87 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Easyband
n=110 participants at risk
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.91%
1/110 • Number of events 2
|
|
Cardiac disorders
Myocardial infarction
|
0.91%
1/110 • Number of events 2
|
|
Gastrointestinal disorders
Gastric dilatation
|
0.91%
1/110 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
1.8%
2/110 • Number of events 2
|
|
General disorders
Asthenia
|
0.91%
1/110 • Number of events 1
|
|
General disorders
Device malfunction
|
2.7%
3/110 • Number of events 3
|
|
General disorders
Medical device complication
|
4.5%
5/110 • Number of events 6
|
|
Infections and infestations
Device related infection
|
0.91%
1/110 • Number of events 1
|
|
Infections and infestations
Incision site infection
|
0.91%
1/110 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
0.91%
1/110 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.91%
1/110 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular accident
|
0.91%
1/110 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.91%
1/110 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
0.91%
1/110 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
Premature baby
|
0.91%
1/110 • Number of events 1
|
|
Psychiatric disorders
Depression
|
1.8%
2/110 • Number of events 3
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.91%
1/110 • Number of events 1
|
|
Surgical and medical procedures
Medical device removal
|
7.3%
8/110 • Number of events 8
|
Other adverse events
| Measure |
Easyband
n=110 participants at risk
|
|---|---|
|
Gastrointestinal disorders
Vomiting
|
38.2%
42/110
|
|
Gastrointestinal disorders
Dysphagia
|
20.0%
22/110
|
|
Gastrointestinal disorders
Abdominal pain upper
|
14.5%
16/110
|
|
Gastrointestinal disorders
Constipation
|
7.3%
8/110
|
|
Gastrointestinal disorders
Dyspepsia
|
7.3%
8/110
|
|
Gastrointestinal disorders
Nausea
|
7.3%
8/110
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.4%
7/110
|
|
Gastrointestinal disorders
Abdominal pain
|
5.5%
6/110
|
|
General disorders
Medical device complication
|
8.2%
9/110
|
|
General disorders
Medical device pain
|
6.4%
7/110
|
|
Surgical and medical procedures
Medical device removal
|
8.2%
9/110
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee At least one month prior to any proposed submission for publication or presentation of trial data, the PI will provide the Sponsor the manuscript for review, comment, and approval. No confidential information may be disclosed without Sponsor's written approval. If it is a multi-center trial, the first publication of the results shall be made in conjunction with the results from other Investigators at other centers.
- Publication restrictions are in place
Restriction type: OTHER