Please select the eligibility criteria that correspond to the clinical trial below.
Title: A RANDOMIZED, SUBJECT AND EVALUATOR-BLINDED, PARALLEL-GROUP, MULTICENTER CLINICAL TRIAL USING AN ENDOSCOPIC SUTURING DEVICE (G-CATH EZ™ SUTURE ANCHOR DELIVERY CATHETER) FOR PRIMARY WEIGHT LOSS
Brief Summary: This is a multicenter, randomized, evaluator and subject blinded, parallel-group, controlled study intended to evaluate the safety and efficacy of treating obese patients with the placement of g-Cath EZ suture anchors followed by a structured diet and exercise plan as compared to a sham procedure followed by the same diet and exercise plan. Subjects will be randomly assigned in a 2:1 ratio to the treatment procedure followed by diet and exercise or the sham procedure followed by diet and exercise. After un-blinding at 12 months post-treatment, sham patients can choose to have the treatment procedure as well.


Options:
A: Inclusion Criteria:

1. Provide written informed consent.
2. Be male or female subjects between the ages of 22-60 years.
3. If female, be either post-menopausal, surgically sterile or agree to practice birth control during year of study and have negative serum HCG at screening and baseline.
4. Have a Body Mass Index (BMI) of ≥30 and \<35 with at least one non-severe co-morbid obesity related condition or a BMI ≥ 35 and \< 40 with or without a non-severe obesity related co-morbid condition, where a severe co-morbid condition is defined as severe if symptoms cause severe discomfort, performance of daily activities is compromised, and/or condition is not entirely controlled with prescription drug therapy.
5. Have had no significant weight change (+/- 5% of total body weight) in last 6 months.
6. Have an American Society Anesthesiologists-PS score ≤ 2 (Appendix III).
7. Agrees not to have any additional weight loss interventional procedures, liposuction, or take any over the counter or prescription weight loss medication for 24 months following study enrollment.
8. Have not taken any prescription or over the counter weight loss medications for at least 6 months and agrees not to utilize for 12 months following study enrollment.
9. Be willing to cooperate with post-operative dietary recommendations and assessment tests.
10. Reside within a reasonable distance from the Investigator's treating office (\~50 miles) and able and willing to travel to the Investigator's office to complete all routine follow-up visits.

Exclusion Criteria:

1. History of (or intra-operative evidence of) prior bariatric, gastric or esophageal surgery.
2. Esophageal stricture or other anatomy and/or condition that could preclude passage of endolumenal instruments.
3. Severe gastro-esophageal 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.
4. Large hiatal hernia (\>3 cm) by history or as determined by pre-randomization endoscopy.
5. Pancreatic insufficiency/disease.
6. Active gastric erosions or gastric/duodenal ulcer.
7. History of gastroparesis or symptoms that would be suggestive of gastroparesis.
8. Pregnancy or plans of pregnancy in the next 12 months.
9. Immunosuppressive medications or systemic steroids (i.e., oral prednisone) within 1 month of Visit 1. Intranasal/inhaled steroids are acceptable.
10. History of inflammatory disease of the GI tract; coagulation disorders; hepatic insufficiency or cirrhosis
11. History or present use of insulin or insulin derivatives for treatment of diabetes
12. Type II Diabetes Mellitus (as defined by HgbA1c \>6.5%) for greater than 10 years at the time of enrollment
13. Quit smoking within the last 6 months at time of enrollment or plans to quit smoking in the year after enrollment
14. Portal hypertension and/or varices.
15. Gastric outlet obstruction or stenosis.
16. Significant abnormality identified during Visit 2 (randomization visit) with endoscopy revealing large hiatal hernia, gastric ulcer, gastric erosions, etc.
17. Patient has a history of drug or alcohol abuse or positive at screening for drugs of abuse.
18. Beck Depression Inventory (Short) Score ≥12 and/or uncontrolled depression after pre-enrollment psychological and medical assessment.
19. Present or past history of psychosis, bipolar disease, or obsessive compulsive disorder after pre-enrollment history and medical /psychological assessment.
20. Non-ambulatory or has significant impairment of mobility.
21. Known hormonal or genetic cause for obesity with the exception of treated hypothyroidism.
22. Participating in another clinical study.
23. Is a relative of investigator or his/her staff, or is employed by investigator or institution involved in the study.
24. Subjects with a personal history of allergic/anaphylactic reactions including hypersensitivity to the drugs or materials that will be utilized in the study procedure.
B: 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.
C: 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
D: 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

Answer: A