ClinicalTrials.gov
ClinicalTrials.gov Menu

European Union (EU) Post-Market Study on Easyband®

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00948246
Recruitment Status : Completed
First Posted : July 29, 2009
Results First Posted : November 26, 2012
Last Update Posted : October 13, 2014
Sponsor:
Information provided by (Responsible Party):
Allergan ( Allergan Medical )

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Morbid Obesity
Intervention Device: Easyband®
Enrollment 112

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Easyband
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 110
Completed 86
Not Completed 24
Reason Not Completed
Lost to Follow-up             11
Adverse Event             11
Death             1
Withdrawal by Subject             1
Arm/Group Title Easyband
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 110
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants
<=18 years
3
   2.7%
Between 18 and 65 years
107
  97.3%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 110 participants
39.0  (11.23)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants
Female
84
  76.4%
Male
26
  23.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 110 participants
Belgium 33
Netherlands 29
Italy 21
United Kingdom 27
1.Primary Outcome
Title Feasibility and Ease of Implantation
Hide Description 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."
Time Frame < 1day
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Easyband
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 110
Measure Type: Number
Unit of Measure: percentage of subjects
Introduction of Easyband into the abdomen 71.8
Placing Easyband around the stomach 81.8
Clipping of the Easyband around the stomach 88.2
2.Secondary Outcome
Title % Excess Weight Loss
Hide Description Percent 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.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Easyband
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 110
Mean (95% Confidence Interval)
Unit of Measure: percentage of excess weight loss
30.73
(29.389 to 35.128)
3.Secondary Outcome
Title Change in BMI
Hide Description Decrease in body mass index (BMI; measured in kg/m2) from baseline to 12 months
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Easyband
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 110
Mean (95% Confidence Interval)
Unit of Measure: kg/m2
-7.23
(-7.898 to 6.560)
4.Secondary Outcome
Title Change in Weight
Hide Description Change in weight (in kilograms) at baseline to 12 months
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Easyband
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 110
Mean (95% Confidence Interval)
Unit of Measure: pounds
-20.70
(-22.754 to 18.640)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Easyband
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Easyband
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Easyband
Affected / at Risk (%) # Events
Total   29/110 (26.36%)    
Cardiac disorders   
Atrial fibrillation  1/110 (0.91%)  2
Myocardial infarction  1/110 (0.91%)  2
Gastrointestinal disorders   
Gastric dilatation  1/110 (0.91%)  2
Nausea  2/110 (1.82%)  2
General disorders   
Asthenia  1/110 (0.91%)  1
Device malfunction  3/110 (2.73%)  3
Medical device complication  5/110 (4.55%)  6
Infections and infestations   
Device related infection  1/110 (0.91%)  1
Incision site infection  1/110 (0.91%)  1
Musculoskeletal and connective tissue disorders   
Sjogren's syndrome  1/110 (0.91%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast cancer  1/110 (0.91%)  1
Nervous system disorders   
Cerebrovascular accident  1/110 (0.91%)  1
Pregnancy, puerperium and perinatal conditions   
Abortion spontaneous  1/110 (0.91%)  1
Pre-eclampsia  1/110 (0.91%)  1
Premature baby  1/110 (0.91%)  1
Psychiatric disorders   
Depression  2/110 (1.82%)  3
Reproductive system and breast disorders   
Menstruation irregular  1/110 (0.91%)  1
Surgical and medical procedures   
Medical device removal  8/110 (7.27%)  8
1
Term from vocabulary, MedDRA 8.0
2
Term from vocabulary, MedDRA (8.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Easyband
Affected / at Risk (%) # Events
Total   87/110 (79.09%)    
Gastrointestinal disorders   
Vomiting  42/110 (38.18%) 
Dysphagia  22/110 (20.00%) 
Abdominal pain upper  16/110 (14.55%) 
Constipation  8/110 (7.27%) 
Dyspepsia  8/110 (7.27%) 
Nausea  8/110 (7.27%) 
Gastroesophageal reflux disease  7/110 (6.36%) 
Abdominal pain  6/110 (5.45%) 
General disorders   
Medical device complication  9/110 (8.18%) 
Medical device pain  7/110 (6.36%) 
Surgical and medical procedures   
Medical device removal  9/110 (8.18%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Medical Monitor
Organization: Allergan Medical
Phone: (805) 961-5000
Responsible Party: Allergan ( Allergan Medical )
ClinicalTrials.gov Identifier: NCT00948246     History of Changes
Other Study ID Numbers: CIP10088
First Submitted: July 28, 2009
First Posted: July 29, 2009
Results First Submitted: June 27, 2012
Results First Posted: November 26, 2012
Last Update Posted: October 13, 2014