Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Controlled Multicenter Feasibility Study of an IncisionLEss Operating Platform for Primary ObeSiTy vs. Diet-exercise Alone: The MILEPOST Study
Brief Summary: This study is a multi-center, open/unblended study (3:1Treatment: Control) to evaluate the safety and effectiveness of the g-Cath EZ Suture Anchor Delivery Catheter as an early weight loss intervention compared to a diet and exercise control only. Mean % Total Body Weight Loss \[TBWL\] in Treatment subjects versus that of Control subjects at 12 months is the primary endpoint. The proportion of subjects achieving ≥ 5% TBWL at 12 months in the treatment group is a co-primary endpoint.


Options:
A: Inclusion Criteria:

* Aged 14 to 16
* Age and sex adjusted BMI \>40 kg/m2 or \>35 kg/m2 with associated co-morbidity.

  \* Associated co-morbidity includes: glucose intolerance, type 2 diabetes, hypertension, pseudotumor cerebri, acanthosis nigricans, obstructive sleep apnoea syndrome, depression, arthropathies, non-alcoholic steatohepatitis and dyslipidemia.
* \> 1 year multidisciplinary organized weight reducing attempts with less than 5% weight loss
* Demonstrate decisional capacity

Exclusion Criteria:

* Psychologically not suitable
* Pre-menarche or bone age \<15 years in boys
* Obesity associated to other disorders such as hypothyroidism
* Syndromal disorders such as Prader-Willi syndrome
* Severe cardiorespiratory impairment (ASA class 3 or higher)
* Insufficiently fluid in the Dutch language
* Unwillingness to adhere to follow-up programmes
B: Inclusion Criteria:

* Age 20-60 years
* Body Mass Index \[BMI\] of \>30 and \<40 with or without a co-morbid condition
* Subject has failed more conservative weight reduction alternatives such as supervised diet, exercise or behavior modification programs in the last year
* No significant weight change (+/- 5% of total body weight) in last 6 months
* American Society Anesthesiologists-Physical Status score ≤ 2 (Appendix III),
* Subject agrees not to have any additional weight loss interventional procedures or liposuction for at least 30 months following study enrollment,
* Has not taken any prescription or over the counter weight loss medications for at least 6 months,
* Signed informed consent.
* Subject is willing to cooperate with post-operative dietary recommendations and assessment tests,

Exclusion Criteria:

* History of (or intraoperative evidence of) bariatric, gastric or esophageal surgery
* Esophageal stricture or other anatomy and/or condition that could preclude passage of endolumenal instruments
* Severe gastroesophageal reflux disease (GERD), defined as symptoms that cause subject severe discomfort, compromise performance of daily activities, and/or condition is not entirely controlled with prescription drug therapy
* Known hiatal hernia \>3 centimeters by history or as determined by Upper Gastrointestinal exam or endoscopy
* Pancreatic insufficiency/disease
* Active peptic ulcer
* Pregnancy or plans of pregnancy in the next 12 months
* Present Corticosteroid Use
* History of inflammatory disease of Gastrointestinal \[GI\] tract; Coagulation disorders; hepatic insufficiency or cirrhosis
* History or present use of insulin or insulin derivatives for treatment of diabetes
* Type II Diabetes Mellitus \[DM\] (as defined by Glycosylated Hemoglobin \[HgbA1c\] \>6.5) for greater than 2 years at the time of enrollment
* Uncontrolled Type II DM (HgbA1c \> 7.0 at screening)
* Quit smoking within last 6 months at time of enrollment or plans to quit smoking in the next year
* Immunosuppression
* Portal hypertension and/or varices
* Active gastric ulcer disease
* Gastric outlet obstruction or stenosis
* Beck Depression Inventory (Short) Score ≥12 (see Appendix IV);
* Subject has a history of drug or alcohol abuse or actively abusing either as defined by Cage and DAST \[drug use\] questionnaires or positive Urinalysis \[UA\] drug screen
* Severe disturbances in eating behavior (i.e. binge eating)
* Known presence of a significant depression, psychosis, or other mood or eating disorder
* Actively treated depression (except for stable treated depression for \>1year and normal \[Beck Depression Inventory \[BDI\] and psych exam)
* Present or past history of psychosis or other mood or eating disorder
* Non-ambulatory or has significant impairment of mobility
* Known hormonal or genetic cause for obesity with the exception of treated hypothyroidism.
* Participating in another clinical study
* Is a first degree relative of investigator, or support staff involved in the study.
* Employed by investigator or institution involved in the study
* Subject is not able to provide written informed consent
C: Inclusion Criteria:

* BMI from 30 to 50 kg / m2;
* Metabolic syndrome (MetS) with abdominal adiposity if there are at least two components of MetS from the following: Increase in fasting plasma glucose: detected before diabetes (HbA1 = 5.7-6.4 or 3-fold increase in fasting plasma glucose:\> 5.6 mmol / l); or previously diagnosed type 2 diabetes (HbA1\> 6.5, or glucose\> 6.1); Arterial hypertension AD 130 / 85 mmHg or receiving antihypertensive therapy; Increased triglyceride levels\> 1.7 mmol / L or a specific treatment for this disorder; Reduction of high-density lipoproteins (HDL-C) \<1.03 mmol / L in men and less than 1.29 mmol / L in women or receiving treatment for this disorder;
* The possibility of treatment for 12 months and the possibility of follow up;
* Informed written consent of the patient for randomization and treatment.

Exclusion Criteria:

* Age is less than 18 or more than 65 years;
* BMI less than 30 kg / m2 and more than 50 kg / m2;
* Drug addiction and alcohol consumption;
* Complete immobilization of the patient (paresis / paralysis);
* Presence in the anamnesis bariatric procedures;
* Insulin-dependent diabetes;
* Mental disorders or taking antidepressants;
* Socially vulnerable categories (according to ethical principles);
* Patients who do not understand the purpose of the study;
* Lack of informed written consent.
D: Inclusion Criteria:

* Adolescents up to age 19
* Approved for bariatric surgery
* Agreement to participate in Teen-LABS Study/ understand and sign Informed Consent/Assent

Exclusion Criteria:

* Age 19 or greater
* Unable to sign Informed Consent/Assent

Answer: B