A Prospective, Open-label Study to Evaluate the Safety and Efficacy of Lap-Band® Adjustable Gastric Band (LAGB®) Operations in the Treatment of Morbidly Obese Adolescents (Ages 14-17)
Phase: NA
Conditions: Obesity, DM
Sponsor: NYU Langone Health

1 
NEW YORK UNIVERSITY SCHOOL OF MEDICINE 
 
A prospective, open-label study to evaluate the safety and efficacy of Lap-Band® Adjustable Gastric 
Band (LAGB®) Operations in the Treatment of Morbidly Obese Adolescents (Ages 14-17) 
 
PROTOCOL DATE:  
April 27, 2004 
AMENDMENT No 1: 
January 05, 2005 
AMENDMENT No 2: 
February 23, 2005 
AMENDMENT No 3:  
April 15, 2005 
AMENDMENT No 4:  
May 25, 2006 
AMENDMENT No 5:  
July 03, 2008 
AMENDMENT No 6: 
June 10, 2010  
AMENDMENT No 7: 
January 28, 2011 
 
AMENDMENT No 8: 
December 22, 2011 
 
AMENDMENT No 9: 
May 01, 2012 
AMENDMENT No 10: 
July 17, 2013 
 
 
PRINICPAL  
INVESTIGATOR: 
 
Christine Ren Fielding, M.D. 
 
 
 
 
Director, Program for Surgical Weight Loss 
 
 
 
 
NYU School of Medicine 
 
 
 
 
530 First Avenue, Suite 10S 
 
 
 
 
New York, NY  10016-6497 
 
CO-INVESTIGATORS:  
George Fielding, M.D. 
 
 
 
 
Department of Surgery 
 
 
 
 
NYU School of Medicine 
 
 
 
 
 
 
 
 
 
 
Marina Kurian, M.D. 
Department of Surgery 
NYU School of Medicine  
 
Bradley Schwack, M.D. 
Department of Surgery 
NYU School of Medicine  
 
 
 
 
 
 
 
 
Glenn S. Hirsch, M.D. 
 
 
 
 
NYU Child Study Center 
NYU School of Medicine 
 
Property of New York University School of Medicine 
 
CONFIDENTIAL 
This document is a confidential communication of NYU School of Medicine.  Acceptance of this document constitutes the 
agreement by the recipient that no unpublished information contained herein will be published or disclosed without the prior 
written approval of NYU School of Medicine, except that this document may be disclosed to appropriate institutional review 
boards/ethical committees so long as they are requested to maintain its confidentiality. 
PROTOCOL SUMMARY  
 
 
1  
NCT00587301 
study 11876

Lap-Band® Adjustable Gastric Band (LAGB®) Operations in the Treatment of Morbidly Obese Adolescents (ages 14-17) 
Version Date: November 10, 2016 
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TITLE OF STUDY: 
 
A prospective, open-label study to evaluate the safety and efficacy of   
 
 
 
 
Lap-Band® Adjustable Gastric Band (LAGB®) Operations in the  
 
 
 
 
 
Treatment of Morbidly Obese Adolescents (Ages 14-17) 
 
 
PRINCIPAL INVESTIGATOR: 
Christine J. Ren Fielding, M.D. 
 
 
 
 
General Laparoscopic Surgery  
 
 
 
 
Director, Program for NYU Langone Weight Management  
 
 
 
 
NYU School of Medicine 
 
 
 
 
530 First Avenue, Suite 10S 
 
 
 
 
New York, NY  10016-6497 
 
PERIOD OF TRIAL: 
 
Jan 2005 –Jan 2019 
STUDY OBJECTIVES: 
 
Is to demonstrate the safety and efficacy of the use of the  
 
 
 
 
 
 
LAP-BAND® System in the morbidly obese adolescent population in   
 
 
 
 
the United States, and therefore provide these individuals with a  
 
 
 
 
 
significantly less morbid and reversible surgical option for weight loss. 
STUDY VARIABLES: 
 
The primary efficacy variable is weight loss evaluated in terms of %  
 
 
 
 
 
excess weight loss (EWL). 
DESIGN: 
 
 
Prospective, open-label, and single center 
 
INCLUSION CRITERIA: 
• 
Be at least 14 and less than 18 years of age at the time of enrollment into the 
study. 
• 
Have a BMI of at least 40. 
• 
Have a history of obesity for at least 5 years, including failed attempts at 
diet and medical management of obesity. 
• 
Confirmation by a psychologist or psychiatrist experienced with adolescents 
that the subject is sufficiently mature emotionally to comply with the study 
protocol. 
• 
Express willingness to follow protocol requirements. 
• 
Assure investigators that subject, if female of childbearing potential, is 
using an appropriate form of contraception. 
 
EXCLUSION CRITERIA: 
• 
Intention or need to have another surgical procedure for weight reduction 
within 12 months of Lap Band placement. 
• 
History of congenital or acquired anomalies of the G.I. tract, such as; 
congenital or acquired intestinal telangiectasia, Crohn's disease or ulcerative 
colitis; severe cardiopulmonary disease or severe coagulapathy; hepatic 
insufficiency or cirrhosis. 
• 
Presence of dysphagia or documented esophageal dysmotility. 
• 
Patients with autoimmune connective tissue disorders. 
• 
Patients with acute abdominal infections. 
• 
Pregnancy or intention of becoming pregnant in the next 12 months. 
• 
Presence of psychiatric problems or immaturity which would compromise 
cooperation with the study protocol. 
• 
History of previous bariatric surgery, intestinal obstruction or adhesive 
peritonitis. 
• 
Presence of localized or systemic infection at the time of surgery. 

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• 
Chronic use of aspirin and/or non-steroidal anti-inflammatory medications 
and unwillingness to discontinue the use of these concomitant medications. 
• 
History of gastric or esophageal surgery. 
• 
Use of weigh loss medications simultaneously. 
 
NUMBER OF SUBJECTS: 
 120 
 
 
 
 
 
 
 
 
 
 
 
 
PRODUCT NAME (USAN) 
LAP-BAND® Adjustable Gastric Band (LAGB®) System  
 
TEST ARTICLE: 
              LAP-BAND® System 
 
 
DURATION OF THERAPY: 
5 years 

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TABLE OF CONTENTS 
1.0 
INTRODUCTION 
1.1 
Background and Rationale 
1.2 
Description of LAP-BAND® System Components 
2.0 
STUDY OBJECTIVES 
2.1 
Primary Objective 
2.2 
Secondary Objective(s) 
3.0 
INVESTIGATIONAL PLAN 
3.1 
Study Design 
3.2 
Study Population 
3.2.1 Inclusion Criteria 
3.2.2 Exclusion Criteria 
3.2.3 Patient selection equitability 
3.2.4 Removal of Subjects from the Trial 
3.3 
Study Duration 
3.4 
Study Procedures 
3.4.1 Subject Screening 
3.4.2 Quality of Life and Psychological Evaluations 
3.4.3 Baseline Evaluations 
3.4.4 Surgery 
3.4.5 Follow-Up Visits 
3.4.5.1 Scheduled Visits 
3.4.5.2 Band Adjustments 
3.4.6 Diet 
3.4.6.1 Postop Week 1 & 2 
3.4.6.2 Postop Week 3 & 4 
3.4.6.3 Postop Week 5 & 6 
3.4.6.4 Postop Week 7 & Beyond 
3.4.7 Termination 
3.5 
Interim Analysis 
3.6 
Adverse Events 
3.6.1 Adverse Events 

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3.6.2 Adverse Event Recording 
3.6.3 Serious Adverse Event Reporting 
3.7 
Data and Statistical Analysis 
3.7.1 Primary Efficacy Variable 
3.7.2 Secondary Efficacy Variable(s) 
3.7.3 Nutritional Status 
3.7.4 Psychiatric Status 
3.7.5 Safety Evaluations 
3.7.6    Statistical Methods 
3.7.7    Data Collection 
3.7.8 Stopping Rules for Adverse Events 
3.7.9 Monitoring the Study 
3.7.10 Data Safety Monitoring Board 
4.0 
Ethics 
4.1 
Ethical Principles 
4.2 
Informed Consent 
4.3 
Institutional Board of Review Associates (IBRA) 
5.0 
REFERENCES 
6.0 
TABLE 
 
Table 1 
Schedule of Visits & Procedures 
APPENDICES 
Attachment for Data Sharing  
Appendix A 
Child Depression Inventory 
Appendix B 
Three-Factor Eating Questionnaire 
Appendix C 
Child Behavior Checklist 
Appendix D 
Youth Evaluation Scale 
Appendix E 
SF-36 Health Survey 

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1.0 
INTRODUCTION 
1.1 
Background and Rationale 
The Lap-Band System is approved by the FDA for use in adults. Studies have demonstrated that 
childhood obesity increases the likelihood of developing numerous co-morbid conditions, 
including: hypertension, diabetes mellitus, pulmonary complications, growth acceleration, 
dyslipidemia, musculoskeletal problems, psychosocial problems, and cancer [1-2].  The severely 
obese patient faces death without proper treatment of the condition. Furthermore, the economic 
impact of obesity is substantial.  It is estimated that the cost of obesity in the U.S. in 2002 dollars 
is $117.1 billion, and, with estimates that obesity could affect two in five adults by the year 
2025, the need to address obesity at an early age is clear. 
It has been shown that the nutritional and behavior modifications necessitated by bariatric 
surgery, as evidenced by the reported success of the gastric bypass procedure in adolescents, are 
safe, and are associated with significant weight loss as well as correction of co-morbid 
conditions and improved self-image and socialization [3-5]. The use of the Lap-Band System 
results in clinically significant weight loss with significantly less operative morbidity and 
mortality than the gastric bypass procedure in adults [6].  Additionally, the adjustability to 
patient needs and the relative ease of reversal is unique to the Lap-Band System. This system has 
been used in adults in Europe and other countries since 1993; international publications report a 
mean Percent Excess Weight Loss (%EWL) of 52% in subjects with 1 year of follow-up and 
68% after 2 years of follow-up [7-9].  In the first US clinical study a mean of 34.6% EWL in 221 
subjects was reported with 1 year follow-up and 38.2% EWL in 122 subjects at 2 years of 
follow-up. However, the first published US experience by Rubinstein of 63 patients showed a 
53% EWL at 3 years [10].   Currently, our experience in adults demonstrates a 44.3% EWL at 1 
year [11].  Finally, the Lap-Band has been shown to be a safe and effective method of weight 
loss in morbidly obese adolescents by Dolan, et.al., in Brisbane, Australia [12].  In fact, when 
compared to matched controlled adults, adolescents did better in terms of weight loss and 
complications [13]. Mortality has been found to be only about 1 in 10,000 [0.01%]; this 
compares with a mortality rate among gastric bypass patients that approaches 0.5% [6]. 
At this time, there is only one surgical option for morbidly obese adolescents: Roux-en Y gastric 
bypass.  We believe that the LAP-BAND®, which can be removed after sufficient weight loss 
and behavior modification, would be a better option for adolescents. 
The lower age limit of children being offered LAGB surgery is open to conjecture.  One of the 
obvious concerns in offering surgery to children as young as twelve years of age is the 
effect surgery may have on the child’s growth. However, there are data available that encourage 
this concept.  Obese children are known to grow faster than non- obese children [14-16]. They 
are taller by at least one standard deviation than their normal weight peers before puberty, and 
then normalize in their late teens. Furthermore, they have higher levels of lean body mass, as 
well as fat mass, corresponding with their height.  Obese girls achieve puberty at a younger age 
than non-obese girls [17-19].  Also, it is typical for morbidly obese children to be taller than 
average, have heavier muscle mass, and for girls to be sexually developed by the age of 12. 

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In contradistinction to Roux-en Y Gastric Bypass (RYGB) and intestinal bypass procedures such 
as the biliopancreatic diversion (BPD) and duodenal switch, LAGB patients suffer no nutritional 
sequelae after surgery [20-23].  There has been no study that describes any nutritional deficiency 
after LAGB, despite a reduction in fat mass by up to 50%. In the first 3 months post-surgery, 
there is a small reduction (5-10%) in lean body mass, which stabilizes at 6 months, with no 
prolonged loss of lean mass thereafter  [24-25].  The greatest disparity between LAGB and 
RYGB or BPD is in Vitamin D and calcium metabolism, which has only been studied in adults. 
Coates et al has recently shown increase in bone turnover and decreased bone mass 9 months 
after RYGB [26]. Newberry et al showed that after intestinal bypass operations, 50% of patients 
were depleted in Vitamin D, with associated hyperparathyroidism in 63% [27].  In concert with 
the data showing no caloric or nutrient malabsorption after LAGB, Pugnale et al showed no 
evidence of secondary hyperparathyroidism 1 year after LAGB [28]. The adult population 
effectively eat approximately 1200-1800 calories per day after LAGB, which equates with 
caloric intake of non-obese adults, and this would presume to be the same in children. In 
addition, all micronutrients and vitamins are completely absorbed.  
 
In a 1975 report of 25 adolescents undergoing Roux-en Y gastric bypass surgery, a 25 % loss of 
body weight at 3 years was observed with no interruption in growth in height over that time 
period [4]. All published series of surgery for severe adolescent obesity, by vertical banded 
gastroplasty, RYGB, BPD or LAGB, include children 12 years of age [5, 12-13,30-33]. One 
includes children as young as 8 yrs old [29]. There is another case report of a 13 year old girl 
with severe renal failure having LAGB [34]. All were associated with severe obesity-related co-
morbidity.  
 
Dolan and Fielding have published two papers on their initial experience with the Lap–Band in 
morbidly obese adolescents [35, 36].  The first paper describes 17 children aged 12 – 19 years, 
weight 129 kg and BMI 45kg/m2. At a median follow – up of 25 months (12–46), BMI fell to 30 
kg/m2, representing 60% EWL. One patient developed a slip needing revision, and another 
needed a port revision, both same day procedures. In a related paper, 17 adults matched for sex, 
weight and BMI were compared to the children, and the children performed marginally better in 
terms of weight loss.  
 
In a subsequent assessment of 26 children aged 12–19 years, with mean 34 month follow up, 
Fielding found that BMI fell from 43 to 29 kg/m2 at 3 years, and was maintained out to 5 years 
[37]. This represents 70% EWL at 3 years. Thirteen of 18 children are no longer obese after 3 
years (BMI < 30kg/m2). Furthermore, compliance for visits and adjustments was very high at 
12.2 visits in 2 years (7–22 visits).  
 
The following table is a brief weight loss report of 14 morbidly obese adolescents aged 13 to 17 
years with BMI 43 to 64 who underwent laparoscopic adjustable gastric banding surgery by Dr. 
Christine Ren and Dr. George Fielding at New York University Medical Center.   No deaths, re-
operations, prolonged hospitalizations, or complications were occurred on those adolescents.  
 
Age 
Initial 
BMI 
OP Date 
6M 
BMI 
6 
M %E
WL 
1Y 
BMI 
1Y 
%EWL 
2Y 
BMI 
2Y 
%EWL 
3Y 
BMI 
3Y 
%EWL 
17 
63 
9/21/2001 
52 
26 % 
47 
39 % 
42 
53 % 
42 
51 % 
17 
64 
4/18/2002 
55 
21 % 
49 
33 % 
46 
41 % 
 
 
17 
47 
8/15/2002 
41 
26 % 
34 
55 % 
35 
50 % 
 
 

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13 
61 
4/26/2004 
52 
22 % 
 
 
 
 
 
 
17 
59 
6/10/2004 
45 
18 % 
 
 
 
 
 
 
17 
51 
6/28/2004 
46 
16 % 
 
 
 
 
 
 
15 
44 
8/5/2004 
 
 
 
 
 
 
 
 
13 
43 
8/6/2004 
32 
53 % 
 
 
 
 
 
 
16 
43 
8/6/2004 
 
 
 
 
 
 
 
 
16 
44 
8/13/2004 
 
 
 
 
 
 
 
 
17 
44 
8/13/2004 
36 
50 % 
 
 
 
 
 
 
15 
42 
10/7/2004 
 
 
 
 
 
 
 
 
16 
51 
10/21/2004 
42 
30 % 
 
 
 
 
 
 
17 
44 
10/22/2004 
 
 
 
 
 
 
 
 
 
There is an excellent opportunity in this proposed protocol to study the effect 
on growth of weight-loss after surgery in morbidly obese children as young as 14 
years. Given that there is no evidence of nutritional sequelae or interruption of 
bone growth after LAGB and since we will be performing nutritional monitoring and bone 
density studies, there would seem to be minimal risk in including these younger children in the 
protocol. 
1.2 
Description of LAP-BAND® System Components  
The implanted components of the Lap Band System include: 
 
1. 
ADJUSTABLE BAND  
The adjustable band component is a 13-mm wide band available in three sizes (an inside 
circumference of 9.75 cm, 10 cm, or 11 cm), which forms a circular ring around the stomach 
when closed.  The band is made of silicone elastomer and the inner surface of the band is 
inflatable, allowing for stoma adjustments.  Radiopaque, kink-resistant tubing is used to connect 
the inflatable section to the access port. 
 
2. 
ACCESS PORT 
The access port consists of a 31 mm-diameter titanium reservoir in polysulfone housing with a 
high-compression silicone septum.  It is used for percutaneous adjustments of stoma diameter 
and is self-sealing when penetrated with the access port needle.  The access port is also supplied 
individually packaged.   
 
A component of the system used for adjustments post-operatively:  
 
3. 
ACCESS PORT NEEDLE 
The access port needles are a 20 gauge and a 22 gauge, 38 mm (1.1/2 inch), non-coring, 
deflected tip ("Huber Needle") needle designed to penetrate the access port for saline volume 
adjustment of the LAGB System.  The access port needle is also available individually packaged 
in packs of 10 for additional stoma adjustments via the access port.  
2.0 
STUDY OBJECTIVES 
2.1 
Primary Objective 

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The primary objective of this research is to demonstrate the safety and efficacy of the use of the 
LAP-BAND® System in the morbidly obese adolescent population in the United States, and 
therefore provide these individuals with a significantly less morbid and reversible surgical option 
for weight loss. 
2.2 
Secondary Objective  
The secondary objective is to assess the status of co-morbidities and changes in quality of life 
and the academic performance from baseline. 
3.0 
INVESTIGATIONAL PLAN 
3.1 
Study Design  
This is a prospective, non-randomized, single-center study to be conducted under an FDA-
approved Investigational Device Exemption (IDE).  One investigational site will enroll and treat 
up to 120 subjects who meet the criteria for use of the LAP-BAND® System, except that they 
are adolescents ages 14 to 17.  Subjects will be followed for five years. 
3.2 
Study Population 
3.2.1 Inclusion Criteria 
1. Be at least 14 and less than 18 years of age at the time of enrollment into the 
study, at Tanner developmental stage 4 or greater, and be past the point of peak 
height velocity.  Bone age will be determined in this evaluation. 
2. Have a BMI of at least 40 [BMI is calculated as follows: BMI = weight (Kg) 
divided by (height (m) squared); i.e. (W/H2) or Kg/m2)].  These criteria are the 
ones recommended by the NIH for adults.  When applied to adolescents, they are 
more conservative than the criteria of BMI > 95th percentile for age because of 
the BMI curves for children and adolescents.  We feel the criteria proposed in 
Pediatrics, 2004;114(1):217-223 are unnecessarily restrictive given the incidence 
of comorbidities starting at a BMI of 35,  the likelihood of the development of 
comorbidities starting at a BMI of 35, and the poor results of therapies which do 
not include bariatric surgery for adolescents with a BMI of 35 or greater. 
3. Have a history of obesity for at least 5 years, including failed attempts at diet and 
medical management of obesity. 
4. Express willingness to follow protocol requirements which include signing an 
assent form, having the individual's legal guardian sign a consent form; 
completing 1-2 week, 6 week, 3 month, 6 month, 9 month, 12 month, and every 6 
month follow-up visits for a total of five years, and completing all protocol-
required laboratory and diagnostic tests. 
5. Confirmation by a psychologist or psychiatrist experienced with adolescents that 
the subject is sufficiently mature emotionally to comply with the study protocol. 

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6. Assure investigators that subject, if female of childbearing potential, is using an 
appropriate form of contraception. 
3.2.2 Exclusion Criteria 
1. Intention or need to have another surgical procedure for weight reduction within 
12 months of Lap Band placement. 
2. History of congenital or acquired anomalies of the G.I. tract, such as; congenital 
or acquired intestinal telangiectasia, Crohn's disease or ulcerative colitis; severe 
cardiopulmonary disease or severe coagulapathy; hepatic insufficiency or 
cirrhosis. 
3. Presence of dysphagia or documented esophageal dysmotility. 
4. Patients with autoimmune connective tissue disorders. 
5. Patients with acute abdominal infections. 
6. Pregnancy or intention of becoming pregnant in the next 12 months. 
7. Presence of psychiatric problems or immaturity which would compromise 
cooperation with the study protocol. 
8. History of previous bariatric surgery, intestinal obstruction or adhesive peritonitis. 
9. Presence of localized or systemic infection at the time of surgery. 
10. Chronic use of aspirin and/or non-steroidal anti-inflammatory medications and 
unwillingness to discontinue the use of these concomitant medications. 
11. History of gastric or esophageal surgery. 
12. Use of weigh loss medications simultaneously 
3.2.3 Patient selection equitability 
We acknowledge the importance of equitability of research subjects in relation to patients’ 
financial circumstances.  Therefore, we will cover all costs for up to twenty percent of the study 
subjects who are unable to pay for professional fees, device fees and hospital costs and study-
related costs.  
Our staff will make every effort to obtain pre-authorization from the patient’s insurance 
company for the surgery. If the insurance company refuses to pay the fees, the patients will be 
charged for the surgery and anesthesia.  All study-related costs will be charged to the subject’s 
family.   Subjects and their parents will be notified of the payment arrangement very early on in 
the recruitment process.  In the event that sufficient funds become available, we will cover all 
costs for whatever number of patients can be supported by these funds.  We are actively seeking 
philanthropic funding to allow as many morbidly obese adolescents access to the study as 
possible. 
3.2.4 Removal of Subjects from the Trial 
 

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A study subject or the parent of the study subject may end their participation in the study at any 
time. If a subject withdraws, the principal investigator will make reasonable effort to determine 
the reason for the subjects’ withdrawal from the study and complete termination procedures as 
described in section 3.4.7.  Telephone calls, registered letters and offers of transportation to the 
investigational site are considered reasonable effort. 
 
In addition, the principal investigator may discontinue a patient’s participation in the study if the 
patient fails to comply with the follow-up evaluation schedule (i.e., if patient missed 3 or more 
sequential follow-up visits.)  
3.3 
Study Duration 
Subjects will be followed for a period of five years post-operatively. 
3.4 
Study Procedures 
All parents or legal guardians of subjects must give their written informed consent in accordance 
with the informed consent regulations in Title 21 of the Code of Federal Regulations, Part 50. All 
subjects must give their written informed assent. 
 3.4.1 Subject Screening 
Subjects will be recruited from among individuals referred to NYU Langone Weight 
Management Program for weight loss procedures.  Both parents and children will be actively 
involved in the subject screening process.  The information obtained from the parents will be 
about the child with minimal information on parent's weight history and family eating 
habits.  Medical, social, psychiatric history and current psychological status, as well as weight 
history and eating disorders will be included in the subject screening. 
3.4.2 Quality of Life and Psychological Evaluations 
As part of the educational program, subjects and their parents will have visits with a nutritionist 
and psychologist before the surgery and at each follow-up visit (as listed below) after the 
operation, so they can be advised on dietary habit changes that will be needed.  These scheduled 
visits will consist of an initial parent interview, initial child interview, questionnaires for the 
child assessing eating habits, degree of depression, degree of anxiety, subjective assessment of 
quality of life, body image satisfaction, self-esteem, and family environment. The parents will 
also be evaluated at scheduled follow-up visits with questionnaires assessing quality of life and 
family environment perceptions.  Psychiatric Status will be evaluated by child study center 
psychologist with the use of an interview, a child behavior checklist (parent and self-report), a 
youth evaluation scale (parent and self-report), a three-factor eating questionnaire, and a child 
depression inventory. 
 
Child Behavior Checklist (CBCL) 
 
The Child Behavior Checklist (CBCL) is a device by which parents or other individuals who 
know the child well rate a child's problem behaviors and competencies. This instrument can 

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either be self-administered or administered through an interview. The CBCL can also be used to 
measure a child's change in behavior over time or following a treatment. The first section of this 
questionnaire consists of 20 competence items and the second section consists of 120 items on 
behavior or emotional problems during the past 6 months. The target age group of the test is 6 
through 18 years old.  Criterion validity was assessed and found to be acceptable.  
 
The Youth Evaluation Scale (Y.E.S.) 
 
The Youth Evaluation Scale (Y.E.S.) is a biopsychosocial assessment instrument for weight-
related problems of boys and girls 12 to 20 years of age. Y.E.S. is designed for individual 
assessment and is a valuable component of the assessment of bulimia and anorexia nervosa. 
Subscales include physical, behavioral, fitness, depression, anxiety, self-esteem, family system, 
communication, and knowledge.  Y.E.S. includes questionnaires for the adolescent and parent(s).  
Answers to over 600 questions are compared to established norms in each subscale. The analysis 
generates the Y.E.S. provider’s summary report which presents historical, sensitive and specific 
information to the clinician. A separate Y.E.S. results report is also generated for 
parent(s) and adolescent education. Follow-up questionnaires and data summaries support the 
evaluation of post-treatment and long term changes.  Using Y.E.S. involves administering the 
questionnaires to the adolescent and parent(s) and collecting data on weight, height and triceps 
skinfold.  
 
Child Depression Inventory (CDI) 
 
The CDI is a self-report, symptom-oriented scale which requires at least a first grade reading 
level and was designed for school-aged children and adolescents. The CDI has 27 items, each of 
which consists of three choices. The child or adolescent is instructed to select one sentence for 
each item that best describes him or her for the past two weeks. QuickscoreTM form scoring 
makes the inventories easy and economical to administer. The CDI profile contains the following 
five factors plus a total score normed according to age and sex: negative mood, interpersonal 
problems, ineffectiveness, anhedonia, and negative self-esteem.  The assessment is designed for 
a variety of situations, including schools, child guidance clinics, pediatric practices, and child 
psychiatric settings. 
 
Three-Factor Eating Questionnaires 
 
51-item three-factor eating questionnaire is to measure three dimensions of human eating 
behavior; (1) 'cognitive restraint of eating', (2) 'disinhibition' and (3) 'hunger'.  
 (See Table I) 
3.4.3 Baseline Evaluations 
• Height and weight 
• Blood pressure  
• Baseline laboratory 
o Metabolic profile (Sodium, Potassium, Chloride, CO2, BUN,   Creatinine, 
Glucose, Calcium)  
o Hematologic profile (Hemogram) 

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o Thyroid panel (T3,  T4, TSH, Free T4) 
o Lipid panel (Total cholesterol, LDL, HDL, Triglycerides) 
o Hepatic function panel (Albumin, Alkaline Phosphatase, Total Bilirubin, 
Direct Bilirubin, ALT, AST, Total Protein) 
o HbA1c and Insulin 
o Nutritional panel (Iron, Folate, B12, Vitamin D 25-Hydroxy, PTH, 
Magnesium, Phosphorus) 
o OGTT (Oral Glucose Tolerance Test) (excluding subjects who have Type 
I or II diabetes) 
• Urinalysis 
• Bone density 
• Chest x-ray 
• EKG 
• Gall bladder ultrasound 
• Serum pregnancy test (for female subjects) 
• Pulmonary Function Testing (if indicated by history and physical) 
• Sleep study (if indicated by history and physical) 
Gastrointestinal evaluation will include:  
• Esophagram 
• Esophageal manometry, (if necessary, to evaluate for esophageal dysmotility if 
patient presents with dysphagia and abnormal esophagram indicating achalasia )  
Nutritional evaluation will include:  
• Initial nutritional assessment 
• 
Follow up nutritional assessment 
Psychiatric evaluation will be evaluated by: 
• Psychiatric Assessment 
• Child Behavior Checklist (parent and self-report, attached: Appendix C) 
• Youth Evaluation Scale (parent and self-report, attached: Appendix D) 
• Child Depression Inventory (CDI, attached: Appendix A) 
• Three-Factor Eating Questionnaire (attached: Appendix B) 
• SF-36 Health Survey (attached: Appendix E) 
3.4.4 Surgery 
 Subjects and parents will be required to attend an intensive pre-op assessment by the bariatric 
team at NYU prior to the operative procedure.  Placement of the Lap-Band System will be 
performed laparoscopically and with the patient under general anesthesia.  Placement of the Lap-
Band via laparotomy will be performed only in cases where conversion is needed.  The surgery 
will be done on an inpatient or outpatient basis.  All patients will receive prophylactic antibiotics. 

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3.4.5 
Follow-Up Visits 
3.4.5.1  
Scheduled Visits 
Study data will be collected at 1-2 week, 6 weeks, 3 months, 6 months, 9 months, 12 months, and 
every 6 months thereafter for a total of five years. Subjects will be weighed and given a physical 
examination. Parents and subjects will meet with the nutritionist at these same visits.   
 The subjects will maintain the behavior modification program worked out with the nutritionist 
and psychologist before surgery.  These programs are individualized to each subject's dietary 
habits, eating habits, and quality of life issues.  The subject will be encouraged and counseled to 
combine their Lap-Band tool with long-term modifications in their lifestyle, including exercise. 
Weight loss, status of pre-operative comorbidities and development of complications will be 
reviewed at every follow-up visit. This will include testing to follow pre-operative 
comorbidities.  Baseline laboratory and nutritional parameters will be repeated every 3 months 
for the first year post op.  OGTT will be performed at 1 year and 5 year on the subjects who have 
impaired glucose tolerance at baseline testing (excluding subjects who have type I or II diabetes 
who is not clinically safe to perform the test).  However, if the HbA1c or fasting blood glucose 
tests show abnormal results or the subject develops polyuria or polydipsia, additional interval 
testing should be performed based on ADA guidelines. 
All laboratory, gastrointestinal, EKG, nutritional, and psychiatric evaluations which were 
performed at baseline will be repeated every 12 months. 
3.4.5.2  
Band Adjustments 
Fluid will be added to or removed from the band as indicated by the clinical progress, physical 
examination, and esophagram done at follow-up visit. 
The adjustments will be performed as per study device manufacture’s DFU. 
Visits for band adjustments can also be initiated by the patient or their course between scheduled 
visits.  If they lose weight too quickly; develop symptoms such as heartburn, nausea, vomiting or 
overeating; or develop a condition or illness requiring them to eat more, they will be evaluated 
for removal of fluid from the band.  If they lose weight too slowly or overeat, they will be 
evaluated for addition of fluid to the band.  Each evaluation will involve review of their clinical 
progress, physical examination, and esophagram if necessary. 
3.4.6  
Diet 
No calorie-specific diets 
No weight loss medications 
Eat slowly and chew thoroughly 
Stop eating when full 

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3.4.6.1  
POST OP Week 1 and 2 
Liquids only moving to full liquids 
3.4.6.2  
POST OP Week 3 and 4 
Blended diet with puree foods 
Do not drink with meals 
3.4.6.3  
POST OP Weeks 5 and 6 
Soft Diet 
Do not drink with meals 
3.4.6.4  
POST OP Week 7 and beyond 
No texture restrictions 
Well balanced low-fat diet 
Do not drink with meals 
Include high fiber and high protein foods 
Three small meals everyday 
Drink 8 cups of liquid everyday 
3.4.7 Termination 
If a subject decides to withdraw from the study and desires the Lap-Band removed, this will be 
done using laparoscopic techniques when possible.  The appropriate follow-up care will be 
provided for those cases, including hospital and clinic follow-up when necessary.  In these cases, 
upper gastrointestinal studies will be performed when necessary. 
After the five-year study is complete, subjects have the option of having the band surgically 
removed or keeping the band.  If the subject chooses to keep the band, they will be followed with 
office visits every six months. 
3.5 
Interim Analysis 
After the first 10 patients have completed 6 months of follow-up, an interim analysis of the 
safety and effectiveness data will be performed and the results submitted to the FDA. 
3.6 
Adverse Events 
3.6.1 Adverse Events 
Peri-operative adverse events include, but are not limited to, nausea and/or vomiting, pneumonia, 
thromboembolism, obstruction, bleeding, peritonitis, infection, and death. 
Post-operative adverse events include, but are not limited to, nausea and/or vomiting, gastric 
prolapse, band erosion, dysphagia, tubing failure, port migration, esophageal dilation and band 
explantation.   

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Potential adverse events related to the Lap-Band® System surgery (per device labeling) include, 
but are not limited to, the following: 
1. Inability to inflate band due to suspected band leak, access port leak, tubing leak, 
obstruction or other condition  
2. Stomach/pouch slippage  
3. Erosion  
4. Suture disruption  
5. Severe infections that require surgical interventions, such as those resulting from 
gastric perforation, subphrenic abscess, necrotizing fasciitis, pancreatic abscess and 
any infection that fails to respond to less invasive treatment (culture required)  
6. Gastric perforation  
7. Splenic injury  
8. Hepatic injury  
9. Pulmonary emboli  
10. Deep vein thrombosis  
11. Serious cardiac/respiratory adverse events (i.e. cardiac/respiratory arrest)  
12. Adverse events, which in the opinion of a rheumatologist, may be related to the band 
(i.e. pain, swelling of joints, tightness, redness or swelling of skin, swollen glands or 
lymph nodes, unusual and unexplained fatigue, and unusual hair loss)  
13. Rashes or other skin reactions  
14. Pain resulting in hospitalization  
15. Any other serious complication that poses a life-threatening condition to the subject 
16. Blood loss resulting in a blood transfusion  
17. Death  
All adverse events will be recorded on appropriate case report form(s). A summary of the 
adverse events including frequency, type, and severity will be reported. 
3.6.2 Adverse Event Recording 
 
Adverse events are intended to be volunteered by subjects or observed by the investigator.  All 
adverse events are to be recorded on appropriate case report forms.  The investigator is instructed 
to report any serious adverse event immediately to the IBRA.   
3.6.3 Serious Adverse Event Reporting 
Any serious adverse event will be reported to the IRB within one business day by 
telephone.  The Chairman of the Institutional Review Board will be notified within one business 
day.   
1. Subject's initials and subject number 
2. Investigator's name 
3. Protocol title and number 
4. Subject's date of birth, gender, and race 

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5. LAP-BAND® System date of implantation surgery 
6. Concomitant medication(s): dose, route, duration of treatment, date of last dose 
7. Information regarding the adverse event: 
• description 
• date(s) the event began and ended 
• whether the experience resulted in death or was life-threatening 
• whether hospitalization was required or prolonged 
• any treatment(s) required 
• outcome(s) of treatment(s) 
• investigator's determination of relationship to the test article(s) 
3.7 
Data and Statistical Analysis 
3.7.1 Primary Efficacy Variable 
The primary efficacy variable is weight loss evaluated in terms of % excess weight loss (EWL). 
3.7.2 Secondary Efficacy Variable(s) 
The secondary variables for evaluation are:  
 
• Body mass index (BMI) 
• Status of co-morbidities 
 Diabetes Mellitus or Impaired Glucose Tolerance 
 Hypertension 
 Asthma 
 Obstructive sleep apnea  
 Dyslipidemia 
 Gastroesophageal reflux disease  
 Urinary stress incontinence 
 Depression 
 Osteoarthritis 
 Back pain 
 Dyspnea and respiratory abnormalities 
• Quality of life scores, depression degree, psychiatric evaluation  
In general, the status of the comorbid conditions will be classified as unchanged, improved, 
resolved, or worsened. For the analysis of change in comorbidity status by the McNemar test, 
unchanged or worsened will be grouped into one category and resolved or improved will be 
grouped into a second category.  For diabetes, this means whether there is change in serum 
HbA1c, insulin, OGTT, or fasting serum glucose or the amount of medication or no need for 
medication,.  For hypertension, this means whether there is change in blood pressure or the 
amount of medication or no need for medication.  For asthma, this means whether there is 
change in the amount of medication or no need for medication.  For sleep apnea, this means 

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whether there is change in the sleep apnea study or a normal sleep apnea study.  For 
hyperlipidemia, this means whether there is change in the lipid panel or the amount of 
medication or no need for medication.  For gastroesophageal reflux, this means whether there is 
change in an annual esophagram or their symptoms.  For urinary stress incontinence, this means 
whether there is change in clinical symptoms. For depression, this means whether there is change 
in the amount of medication or no need for medication or specified psychiatric evaluations. 
3.7.3 Nutritional status 
 
Nutritional status will be evaluated by a registered dietician with the use of initial nutritional 
assessment and follow up nutritional assessment.  Nutritional panel (Iron, Folate, B12, Vitamin 
D 25-Hydroxy, PTH, Magnesium, Phosphorus) will be performed every 3 months for the first 
year and then annually for 5 years. 
 
3.7.4 Psychiatric Status  
 
Psychiatric Status will be evaluated by child study center psychologist with the use of an 
interview, a child behavior checklist (parent and self-report, a standard screen for general 
psychopathology), a youth evaluation scale (parent and self-report, YES has been utilized with a 
particular educational weight loss program to assess readiness for treatment as well as screen for 
psychopathology), a three-factor eating questionnaire (to measure three dimensions of human 
eating behavior, 1) cognitive restraint of eating, 2) disinhibition, and 3) hunger), and a child 
depression inventory (a standard screen for depression).  Status of quality of life will be 
evaluated objectively with a standardized SF-36 Health Survey.  
 
3.7.5 Safety Evaluations 
 
Mortality: 
Thirty day mortality will be evaluated to monitor death, which may have been directly 
related to the intervention.   
 
Esophageal dilation:  
The long-term effects of gastric banding on esophageal motility are unknown.  The risk 
of chronic esophageal dilatation with loss of peristalsis is theoretical and unproven.  
Annual post-operative esophagrams will be performed to monitor esophageal anatomy 
and band positioning. If necessary, esophageal manometry will be performed to evaluate 
for esophageal dysmotility if patient presents with dysphagia and abnormal esophagram 
indicating achalasia. 
 
Nutritional deficiency: 
Although there has been no known nutritional deficiency linked with gastric banding, 
there have been no long-term studies that measure biochemical markers of nutrition or 
evaluation of eating behavior.  Potential nutritional deficiencies will be monitored with 
annual blood work and nutritional evaluations, as described.   
3.7.6 Statistical Methods  
Change in the primary efficacy endpoint, % EWL, will be evaluated by a linear modeling in 
which the covariance among repeated measures of weight loss from month 6 to month 60 is 

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modeled.  SAS PROC MIXED will be used in which two covariance structures will be examined 
by means of a REPEATED statement: unstructured (UN) and autoregressive (AR(1)).  AIC will 
be examined to determine the most suitable structure. In the case that AR(1) is selected, a 
RANDOM statement for Subject will be included in the model.  The predictive variable of 
greatest interest in the model is time.  % EWL is expected to increase after surgery, more quickly 
initially, and then more slowly.  To test for this decelerating trend, Time will be log 
transformed.  The residuals of the model will be examined, especially those relative to predicted 
weight loss over time to ensure that the model is not over or under predicting over the course of 
follow-up.   Systematic departures of the residuals from the predicted time course may require 
adding a quadratic trend to the model or the choice of a different transformation for 
time.  Covariates used in the model will include baseline weight (as measured by BMI).  
The null hypothesis is that % EWL will remain unchanged (i.e., at zero) post surgery.  The 
alternate hypothesis is that % EWL will be positive post surgery.  An alpha of 0.05 will be used 
to determine if the null hypothesis is rejected.  The form of the weight loss over time is not part 
of the hypothesis of the study, but instead is included to better understand the expected trend 
weight loss follows. 
The secondary efficacy endpoint, BMI, will be tested using a model similar to that used to test % 
EWL.  The covariance structure selected for the modeling of % EWL will be applied in the 
modeling of BMI.  Similarly, the same transformation of time will be applied to this 
endpoint.  Baseline BMI will not be included as a baseline covariate, but instead will be assigned 
a value of time 0 and will be included as an endpoint measure. The null hypothesis is that BMI 
will show no change from time of surgery.  The alternate hypothesis is that BMI will decrease 
after surgery. 
The secondary efficacy endpoint of change in co-morbidities will be examined by McNemar 
tests.  The null hypothesis is that there is no change in each co-morbidity post surgery.  The 
alternate hypothesis is that there will be a change in each co-morbidity. 
The secondary efficacy endpoint of quality of life change, as measured by the SF36 scale, will be 
examined by testing the mean change against the null hypothesis of zero (no change) by means 
of a paired t-test.  The alternate hypothesis is that improvements will be seen between pre and 
post surgery in SF36 scale scores.  A further analysis will examine whether change in SF36 scale 
scores is correlated with amount of weight lost. 
The secondary efficacy endpoint of depression change, as measured by the child depression 
inventory, child behavior checklist, and youth evaluation scale, will be examined by testing the 
mean change against the null hypothesis of zero (no change) by means of a paired t-test.  The 
alternate hypothesis is that improvements will be seen between pre and post surgery in 
depression inventory scores.  A further analysis will examine whether change in depression is 
correlated with amount of weight lost. 
Descriptive statistics will be provided for secondary variables such as nutrition status, psychiatric 
evaluations, etc. 

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3.7.7 Data Collection 
Data will be collected by the principal investigator, the nurse practitioner, or nutritionist and 
documented on a standardized data form. The data will be entered by a research coordinator or 
the principal investigator in a fashion that maintains patient anonymity, using a unique 
identification number.  The data will be entered into a secure computerized database, which can 
be accessed only by the principal investigator and the research coordinator with the use of a 
password.  Data collection and statistical analysis will be performed by assigned research 
personnel, who will access the data using the unique patient identification number assigned.  
We will collect relevant life history information from the subject's medical records including 
illnesses and hospitalizations that occur while subjects are participating in the research, as well 
as age, ethnic background, marital status, medical history, weight loss, changes in weight-related 
medical conditions, and information about the surgery and information about lap-band 
adjustments, and complications. We will collect medical information from physicians and other 
healthcare providers in General Surgery, Pediatric Surgery, Pediatrics, Psychiatry, and 
Psychology and from the NYU hospital medical records.  
All data will be recorded on case report forms and compared at 6, 12, 24, 36, 48, and 60 months 
with baseline.  Results will be reported descriptively as well as by modeling weight loss in order 
to assess aggregate outcomes and address the issues of safety and efficacy. 
3.7.8 Stopping Rules For Adverse Events 
 
The trial will be terminated if two or more patients die due to the surgery.  The trial will be 
terminated if during the follow-up period two or more of the first 25 patients implanted have 
developed esophageal dilation.  The trial will also be terminated if during the follow-up period 
two or more of the first 35 patients implanted develop a nutritional deficiency. 
 
3.7.9 Monitoring the Study 
 
Dr. Christine Ren Fielding’s designee will monitor the study progress as frequently as is 
necessary to assure compliance with Good Clinical Practices and protocol procedures and to 
monitor completion of case report forms.  All records pertaining to the study will be made 
available to clinical research associate at each monitoring visit.  The investigational facilities, 
case report forms, patient records, and all other study documentation will be available for 
detailed review.  Arrangements for monitoring visits will be agreed in advance of planned visits, 
except in the case of an emergency.   FDA representatives reserve the right to visit sites at any 
time. 
 
3.7.10 Data Safety Monitoring Board 
 
The data safety monitoring board will be composed of three independent physicians who 
expertise in the treatment of obesity, clinical trials, and statistical knowledge. 
 
DSMB will meet quarterly and the location will be determined at least 2 weeks before the 
meeting date.  The main responsibility of DSMB is to monitor data to provide evidence for 

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safety concerns and recommendations for study continuation, discontinuation, or modification 
due to benefit vs. harm. 
 
The following data will be reviewed by DSMB. 
1. baseline data 
2. safety data 
3. efficacy data 
 
A third party surgeon, Dr. Evan Nadler, who is not affiliated with NYU SOM and NYU Hospital 
will serve as the safety monitor.   
 
Evan P Nadler MD 
Co-Director, Children’s National Obesity Institute 
Associate Professor of Surgery and Pediatrics 
The George Washington University School of Medicine & Health Sciences 
Children’s National Health System 
111 Michigan Avenue, NW 
Washington, DC 20010 
 
The appointed surgeon will monitor the safety data every year and will review all SAEs.  All 
SAEs will be reported to the appointed surgeon within 10 days regardless the relationship to the 
study procedure. 
 
4.0 
Ethics 
 
4.1 
Ethical Principles 
 
This study will be conducted in accordance with Title 21 of the Code of Federal Regulations, 
Part 812 on Investigational Device Exemptions.  Specifically, this study is based on Good 
Clinical Practices; the study will be conducted under a protocol reviewed by the New York 
School of Medicine Institutional Board of Review Associates (IBRA); the study is to be 
conducted by scientifically and medically qualified persons; the benefits of the study are in 
proportion to the risks; the rights and welfare of the subjects will be respected; the physicians 
conducting the study will ensure that the hazards do not outweigh the potential benefits;  the 
results to be reported will be accurate; subjects will give their informed consent and will be 
competent to do so and not under duress; and the ethical principles in Title 21 of the Code of 
Federal Regulations will be complied with. 
 
4.2 
Informed Consent 
 
This study will be conducted in full compliance with the informed consent regulations in 21 
Code of Federal Regulations 50.  Written informed consent will be given by all subjects 
participating in this study in accordance with the 21 CFR 312, 600, and 812.  The consent form 
must be reviewed and approved by the IBRA prior to initiation of the study.  The consent form 
must contain a full explanation of the possible advantages, risks, alternate treatment options, and 
availability of treatment in the case of injury, in accordance with Title 21 of the Code of Federal 
Regulations.  The consent should also indicate that, by signature, the subject, or where 
appropriate, legal guardian, permits access to relevant medical records by representatives of the 
FDA. 

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The investigator is responsible for obtaining written consent from potential subjects prior to 
performing any trial tests or assessments required by the protocol.  A copy of the signed consent 
document will be given to the subject and the original retained by the investigator with the site's 
copy of the case report forms. 
 
4.3 
Institutional Board of Review Associates (IBRA) 
 
This study will be conducted in full compliance with the New York University School of 
Medicine Institutional Board of Review Associates policies and procedures and the regulations 
in 21 CFR 812 and 56.  
 
This protocol will not be initiated unless it has been reviewed and approved by, and remains 
open to continuing review by the IBRA meeting the requirements of 21 CFR 812.42. The IBRA 
shall review and have the authority to approve, require modification of (to secure approval), or 
disapprove the protocol.  The IRB shall notify the investigator in writing of its decision.  The 
IBRA shall require that the information given to subjects as part of the informed consent is in 
accordance with 21 CFR 812.43 and 50.25.  The IBRA shall conduct continuing reviews of the 
protocol at intervals appropriate to the degree of risk, but not less than once per year.  Further, at 
the completion or early termination of the trial, a final report should be made to the IBRA by the 
investigator within 90 days.  
 
Any change or revision in the protocol that significantly affects the safety of the subjects, the 
scope of the investigation, or the scientific quality of the trial must be approved by the IBRA 
prior to implementation.  However, any protocol change intended to eliminate an apparent 
immediate hazard to the subject may be implemented immediately if the FDA is subsequently 
notified of the amendment by the investigator and the IBRA is informed by the investigator. [21 
CFR 812.40] 
 
It is the investigator's obligation to maintain an IBRA correspondence file, and to make this file 
available for review as part of the trial monitoring process. [21 CFR 812.140] 
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39. Hassenstab JJ, Sweat V, Bruehl H, Convit A. Metabolic Syndrome Is Associated with 
Learning and Recall Impairment in Middle Age. Dement.Geriatr.Cogn Disord. 
2010;29(4):356-362. 
40. Yau PL, Javier D, Ryan CM, et al. Structural and Functional Brain Complications in 
Obese Adolescents with Type 2 Diabetes Mellitus  Under Submission. Under Submission 
2008. 

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41. Egger JR, Bartley KF, Benson L, Bellino D, Kerker B. Childhood Obesity is a Serious 
Concern in New York City: Higher Levels of Fitness Associated with Better Academic 
Performance. NYC Vital Signs. 2009;8(1):1-4. 
 
 
 
6.0 Table I 
 
 
 
Schedule of Visits and Procedures 
 
 
 
 
Visit 
1 
Visit 
2 
Visit 
3 
Visit 
4 
Visit 
5 
Visit 
6 
Visit 
7,9,11,
13 
Visit 
8,10,11,14 
>18 yrs old 
(high school 
graduation) 
Procedure 
Screening 
PreOP 
OP 
Week  
1-2 
Week 
6 
3 m 
6 m 
9 m 
1 Y 
Every 
6m 
2 Y, 3Y, 
4Y, 5Y 
 
Informed Consent  
Χ 
 
 
 
 
 
 
 
Χ 
 
Χ 
 
Additional IC for high school 
grades 
 
 
 
 
 
 
 
 
 
 
 
X 
Inclusion/Exclusion Criteria 
Χ 
 
 
 
 
 
 
 
 
 
 
 
Complete Physical Exam 
Χ 
 
 
 
 
 
 
 
Χ 
 
Χ 
 
Demographics Information 
Χ 
 
 
 
 
 
 
 
 
 
 
 
Medical History 
Χ 
 
 
 
 
 
 
 
 
 
 
 
Wt Loss History 
Χ 
 
 
 
 
 
 
 
 
 
 
 
Co-morbidities and 
Concomitant Medications 
Χ 
 
 
 
 
 
 
 
Χ 
Χ 
Χ 
 
Lap-Band Implant/Revision 
 
 
Χ 
 
 
 
 
 
 
 
 
 
Lap-Band Adjustment* 
 
 
 
Χ 
Χ 
Χ 
Χ 
Χ 
Χ 
Χ 
Χ 
 
Follow up Clinical 
Assessment 
 
 
 
Χ 
Χ 
Χ 
Χ 
Χ 
Χ 
Χ 
Χ 
 
Labs  
 
 
 
 
 
 
 
 
 
 
 
 
Metabolic Panel 
 
Χ 
 
 
 
Χ 
Χ 
Χ 
Χ 
 
Χ 
 
Hematology Panel 
 
Χ 
 
 
 
Χ 
Χ 
Χ 
Χ 
 
Χ 
 
Thyroid Panel 
 
Χ 
 
 
 
Χ 
Χ 
Χ 
Χ 
 
Χ 
 
Lipid Panel  
 
Χ 
 
 
 
Χ 
Χ 
Χ 
Χ 
 
Χ 
 
Hepatic Function Panel 
 
Χ 
 
 
 
Χ 
Χ 
Χ 
Χ 
 
Χ 
 
Nutritional Panel 
 
X 
 
 
 
X 
X 
X 
Χ 
 
Χ 
 
HbA1c & Insulin 
 
Χ 
 
 
 
X 
X 
X 
Χ 
 
Χ 
 
OGTT* 
 
Χ 
 
 
 
 
 
 
*Χ 
 
*Χ 
 
Urinalysis 
 
X 
 
 
 
 
 
 
X 
 
X 
 
Serum Pregnancy Test (If 
female) 
 
Χ 
 
 
 
 
 
 
Χ 
 
Χ 
 
EKG 
 
Χ 
 
 
 
 
 
 
Χ 
 
Χ 
 
Pulmonary Function Test 
(If indicated) 
 
Χ 
 
 
 
 
 
 
Χ 
 
Χ 
 
Chest X-Ray 
 
Χ 
 
 
 
 
 
 
 
 
 
 
Gall bladder ultrasound 
 
Χ 
 
 
 
 
 
 
 
 
 
 
Bone Density 
 
Χ 
 
 
 
 
 
 
 
 
 
 
Gastrointestinal Evaluation 
 
 
 
 
 
 
 
 
 
 
 
 
Esophagram 
 
Χ 
 
 
 
 
 
 
Χ 
 
Χ 
 
Esophageal manometry (if 
necessary) 
 
Χ 
 
 
 
 
 
 
Χ 
 
Χ 
 
Sleep Apnea Test (if  
indicated) 
 
Χ 
 
 
 
 
 
 
Χ 
 
Χ 
 
Psychiatric Evaluation 
 
 
 
 
 
 
 
 
 
 
 
 
Psychiatric Assessment* 
Χ 
 
 
 
 
*X 
*X 
 
Χ 
 
Χ 
 
Child Depression Inventory 
X 
 
 
 
 
 
 
 
Χ 
 
Χ 
 
Three-Factor Eating 
Questionnaire 
X 
 
 
 
 
 
 
 
Χ 
 
Χ 
 

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*OGTT will be performed at 1 year and 5 year on the subjects who have impaired glucose tolerance at baseline testing (excluding 
subjects who have type I or II diabetes wh is not clinically safe to perform the test).  However, if the HbA1c or fasting blood 
glucose test show abnormal results or the subject develops polyuria or polydipisa, additional testing should be performed based 
on ADA guidelines. 
*Additional follow up psychiatric assessment will be performed at 3 months and 6 months for the patients with antidepressants 
and moderate to severe psychiatric history. 
Attachment for data sharing 
Adolescent Lap-Band IDE (ALIDE) Study Group 
Mission and Scope 
Introduction 
Obesity has become the most common life threatening disease affecting children in the United 
States.  Bariatric surgery has been suggested as the only reliable means effecting significant 
weight loss in morbidly obese children, and protocol-controlled research into the application of 
the LapBand in treatment programs for adolescent obesity has been ongoing since 2005.  The 
FDA will soon consider approving the use of the LapBand in treatment programs for adolescent 
obesity. Thus, results of the previous and ongoing research will be vital to the FDA 
considerations and to the obese adolescents who need access to surgery.  These results need to be 
pooled, presented at the FDA panel, and published so as to best advocate for FDA extension of 
the indication for the device to ages less than 18, and to advocate for morbidly obese adolescents 
who currently have only the gastric bypass as a surgical option. 
Independent IDE Studies 
In 2001 the FDA approved the LapBand for use in morbidly obese adults.  They specifically 
listed age less than 18 years as a contraindication to the use of the LapBand. In 2004, Dr. Mark 
Holterman of the University of Illinois at Chicago went to the FDA meeting regarding the 
LapBand and adolescents. Once again, use of the LapBand in children less than 18 years old was 
not approved.  After that Dr. Mark Holterman worked with Dr. Ai-Xuan Holterman, Dr. Allen 
Browne and Dr Santiago Horgan to get an Investigational Device Exemption (IDE) from the 
FDA to study the LapBand in morbidly obese adolescents in a weight management program at 
the University of Illinois at Chicago – IDE #1.  Subsequent to that, the group at the University of 
Illinois at Chicago worked with groups at New York University (Drs Ren, Fielding, Nadler),  at 
Morgan Stanley Children’s Hospital (Dr Zitsman), and at A.I. Dupont Children’s Hospital (Dr 
Reichert) as they obtained IDE’s number 2,3, and 4 respectively.  The only support from 
Allergan for these studies was the donation of LapBands to the University of Illinois at Chicago.  
Each group developed unique methods to fund their studies.  These 4 groups now have a 
Child Behavior Checklist 
Χ 
 
 
 
 
 
 
 
Χ 
 
Χ 
 
Youth Evaluation Scale 
Χ 
 
 
 
 
 
 
 
Χ 
 
Χ 
 
SF-36 Health Survey 
Χ 
 
 
 
 
 
 
 
Χ 
 
Χ 
 
Nutritional Evaluation 
 
 
 
 
 
 
 
 
 
 
 
 
Initial Nutritional Assessment 
Χ 
 
 
 
 
 
 
 
 
 
 
 
Follow up Nutritional 
Assessment 
 
X 
X 
Χ 
Χ 
Χ 
Χ 
Χ 
Χ 
X 
Χ 
 
Adverse Event Evaluation 
 
Χ 
Χ 
Χ 
Χ 
Χ 
Χ 
Χ 
Χ 
X 
Χ 
 

Lap-Band® Adjustable Gastric Band (LAGB®) Operations in the Treatment of Morbidly Obese Adolescents (ages 14-17) 
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combined experience with over 150 morbidly obese adolescents who have used the LapBand in a 
multidisciplinary weight management program. These patients are 1-5 years out from the 
placement of their LapBand and have been managed with very similar protocols. All their studies 
are IRB approved at their local institutions and the pooled results will be acceptable for journal 
publication.   
ALIDE Study Group 
Recognition of the problem of morbidly obese children has increased greatly over the last ten 
years. Many organizations and many grants and studies have occurred to work on prevention of 
obesity in children. However, 20-50 % of different populations of children have BMI’s that are 
already over the 95th %tile for their age and gender.  These children are already obese and 
prevention is not appropriate for them. Very little work and study has been done on effective 
therapy for morbidly obese children.  The TeenLabs study from the NIH has published data on 
comorbidities of morbidly obese adolescents, resolution of comorbidities with successful weight 
loss with gastric bypass surgery in morbidly obese adolescents, and the short term morbidity and 
mortality of gastric bypass surgery in morbidly obese adolescents.  
The groups at the University of Illinois at Chicago and New York University have individually 
published short term safety and efficacy, as well as resolution of comorbidities, in  morbidly 
obese adolescents after LapBand surgery. The opportunity now exists for the groups with IDE’s 
#1,2,3, and 4 to pool their data on the safety and efficacy of the LapBand in morbidly obese 
adolescents.  This data would be useful for the upcoming FDA panel consideration of the 
LapBand in morbidly obese adolescents as it will have as many, if not more, patients as the 
industry-sponsored multicenter trial and many patients will have longer follow-up.  Furthermore, 
these data should published as the most extensive data so far from weight management programs 
for morbidly obese adolescents that utilize a surgical approach. 
 
Project Plan and Output:  
The adolescent LapBand IDE Study Group (ALIDE) was formed to achieve pooling of the data 
from the IDE’s at the University of Illinois at Chicago, New York University, Morgan Stanley 
Childrens Hospital, and A.I. Dupont Children’s Hospital. Also included in ALIDE study group 
are Dr. Allen Browne and Dr. Evan Nadler, who were part of the initial IDE work but have since 
left the institutions listed above.   
The ALIDE study group will contact and coordinate with each of the investigators and institutes 
to acquire a copy of their study data which will be provided to the ALIDE Study group in a de-
identified manner, such that no patient can be identified by the ALIDE Study group. The ALIDE 
Study group will then pool the data from each institute, further de-identifying the patients prior 
to  evaluating and analyzing the data by linear modeling. The data will then be prepared for 
publication, in a peer-reviewed journal.  The data will also be presented to the FDA Pediatric 
Advisory Committee in the fall of 2010 to support the use of the LabBand in adolescents. 

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Plan of Action 
1. IRB Approval  
The ALIDE Study Group project coordinator, Bonnie Kuehl, will work with each site to 
achieve IRB approval for the ALIDE Study group project which is to acquire a copy of the 
de-identified patient data from the four institutions, followed by pooling and analysis of the 
data and then publication. 
 
Key Personnel at each Site: 
NYU: Youn (Allison) Heekoung 
UIC: Sandra Gomez and Melissa Satterlee 
A.I. Dupont: Dr. Kirk Reichard 
Morgan Stanley:  
 
2. Data Transfer 
The data will be transferred electronically in a secure manner from each study site as laid out 
in the ALIDE Study Group Data Transfer Protocol dated March 31, 2010 (Appendix 1). This 
SOP ensures that patient data is deidentified by the participating site such that any 
information that can be used to independently identify the identity of any patient will be 
removed or replaced with non-specific information prior to the data transfer to 
ConscienHealth. The data will then be deidentified again prior to the pooled data analysis.  
Note, the data will not be transferred from the ALIDE Study Group secure site once received. 
 
3. Data Analysis 
The data from each institute will be pooled and further de-identified prior to evaluating and 
analyzing the data by linear modeling. The ALIDE study group has identified and agreed 
upon the data fields (Appendix 2) for which they hope to acquire data from each institute to 
complete the pooled analysis. The agreed upon data fields will not include date of birth, if 
needed age will be calculated or estimated.  
 
4. Publication/Presentation 
Once the data analysis is complete the data will then be prepared for publication in a peer 
reviewed journal deemed appropriate by the ALIDE study group and the investigators from 
each site.  The data will also be presented to the FDA Pediatric Advisory Committee in the 
fall of 2010 to support the use of the LabBand in adolescents. In all 
publications/presentations the lead investigator from each site and the institution will be 
acknowledged for their involvement in the project. 
 
 

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APPENDIX 1 
 
ALIDE Study Group Data Transfer Protocol 
Approved: March 31, 2010 
 
Prior to transfer 
• Each participating site will be provided with the specific data element requirements that 
will need to be included with the submission package. 
• All data will be submitted in an electronic format. 
• Prior to submission, the data will be de-identified by the participating site such that any 
information that can be used to independently identify the identity of any patient will be 
removed or replaced with non-specific information. 
• Each patient will be assigned an identification number and the information linking an 
identification number with the patient will be held by the participating site and not 
distributed to any groups outside the participating site. 
• Following the collection and preparation of the data in a suitable electronic format, the 
data will be transferred, as follows. 
 
Data Transfer 
• Each site will be provided with a URL (address) for a secure web server. 
• Security will be established using SSL and identification accomplished by using self-
signed certificates. Each site will be provided with a guide to ensure that the certificates 
are accepted by the browser and a connection with the web server is established.  Due to 
the limited number of participating sites, a certificate signed by an outside agency will be 
not obtained. 
• Prior to allowing data transfer, the web server will ensure that a secure connection is 
established; if the connection is established using an insecure mechanism, the client will 
be redirected automatically to the secure mechanism. 
• The participating site will be presented with an authentication page to provide both a user 
ID and a password; both will be provided with the data requirements package. 
• Upon successful authentication using user ID, the site will be presented with a page to 
select a file to download.  The participating site will then download a file with the de-
identified data to the secure web server. 
 
Following Transfer 
• Following transfer, the web server will move the copied file to a secure, web non-
accessible location. Following transfer, the data file will no longer be available to the 
participating site, or any other public site. 
• The information package will no longer be distributed through the public internet but will 
be physically transferred using portable electronic methods or using private and secure 
networks. 
 
Data Safeguards 
• File transfer will be only allowed using SSL encrypted file transfer protocols. 
• Authentication and data upload will be only allowed for participating sites and will be 
secured by unique passwords and user information. 

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• In the unlikely event that the transferred data is intercepted or otherwise is obtained, the 
information will not contain information that will allow for the independent identification 
of individual patients, but will require further information held by the participating site to 
allow patient information. 
• The information to allow identification of patients will not be requested by the study and 
will not be transferred outside of the study site. 
 

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APPENDIX 2 
Data Field Request- June  2010 
 
1 
Age at surgery (Date of birth will not be given, if needed age will be calculated or 
estimated) 
2 
Height at surgery 
3 
Weight at surgery – before preop diet 
4 
BMI at surgery - before preop diet 
5 
Duration of surgery (if data exists) 
6 
Age at onset of obesity (if data exists) 
7 
Length of preop preparation – months  (not needed for FDA) 
8 
Length of hospitalization - days 
9 
Operative complications – list 
10 
Readmissions within 30 day post op – Y/N 
11 
Preop comorbidities 
a) OSA 
b) Pseudotumor cerebri 
c) Hypertension 
d) Abnormal EKG 
e) Abnormal cardiac ECHO 
f) Asthma 
g)  GERD 
h) NASH 
i) PCOS 
j) SCFE 
k) Diabetes 
l) Prediabetes – abnormal GTT or 
elevated fasting insulin 
m) Hyperlipidemia 
n) Kidney disease 
 
12 
Preop Evaluations 
a) EKG (if data exists) 
b) Cardiac ECHO (if data exists) 
c) Fasting glucose 
d) Fasting insulin 
e) GTT 
f) LFT’s 
g) Lipids 
h) Nutritional Panels (if data exists) 
i) Quality of life evaluations (if data 
exists) 
j) Depression questionnaire (f data 
exists) 
13 
Items monitored post op – 3 months, 6 
months, 9 months, 12 months, 18 months, 
2 years, 2.5 years, 3 years, 3.5 years, 4 
years, 4.5 years, 5 years  
a) Height  
b) Weight 
c) BMI 
d) EKG (if data exists) 
e) Cardiac ECHO 
f) Fasting glucose (yearly only) 
g) Fasting insulin (yearly only) 
k) Nutritional Panels (if data exists) 
l) Quality of life evaluations (if data 
exists) 
m) Depression questionnaire (if data 
exists) 
n) GTT (yearly only) 
o) LFT’s (yearly only) 
p) Lipids (yearly only) 
q) Nutritional Panels (if data exists) 
r) Quality of life evaluations (if data 
exists) 

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h) GTT (yearly only) 
i) LFT’s (yearly only) 
j) Lipids (yearly only) 
s) Depression questionnaire (if data 
exists) 
14 
Healthcare issues post op 
a) Hospitalizations 
b) Operations 
c) New medical problems 
15 
Post op care (if data exists) 
a) Scheduled visits to weight management program – each year 
b) Unscheduled visits to weight management program – each year 
c) AGB adjustments – each year