Please assess the completion status of the following clinical trial:

Trial Title: A Prospective, Randomized Multicenter Study to Evaluate the Safety and Efficacy of the ReShape Duo™ Intragastric Balloon System in Obese Subjects

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: None
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion criteria:~* Patients 21 to 60 years of age~* Body Mass Index (BMI) ≥ 30 kg/m\^2 and ≤ 40 kg/m\^2~* At least 5 years of obesity (with BMI ≥ 30)~* Stable weight, defined as a subject who has not gained or lost ≥ 5% of body weight in the 3 months preceding the screening assessment~* Failure to lose weight, within the 36 months preceding the screening date, after participation in either of the following:~  1. A medically or commercially supervised weight loss program involving regular counseling regarding both diet and exercise.~ 2. Use of a United States Food and Drug Administration (FDA)-approved diet drug~* The presence of one or more obesity-related comorbid conditions~* Willing and able to provide Informed Consent~* Willing and able to comply with study procedures and visit schedules as specified by the protocol~* If female, the patient must~  1. be postmenopausal for at least 1 year OR~ 2. be surgically sterile, OR~ 3. if of child bearing potential, must be practicing birth control, be willing to avoid pregnancy for the year of study participation, have a negative serum pregnancy test at screening, and a negative urine pregnancy test at baseline~* Residing within a reasonable distance from the Investigator's treating office and able and willing to travel to the Investigator's office to complete all routine follow-up visits.~Exclusion criteria:~* History of and/or ongoing clinically significant conditions or disorders of the gastrointestinal (GI) tract~* Clinically significant and uncontrolled/unstable hepatic, reproductive, gastrointestinal, renal, hematologic, pulmonary, neurologic, psychiatric, respiratory, endocrine, or cardiovascular system diseases~* Significant acute and/or chronic infections of any kind.~* Severe coagulopathy, hepatic insufficiency or cirrhosis~* Uncontrolled or severe asthma, or any asthma requiring or likely to require inhaled steroid therapy during the anticipated duration of trial participation~* Severe obstructive sleep apnea~* Incompletely controlled hypothyroidism or hyperthyroidism~* Severe systemic disease \[consistent with an ASA (American Society of Anesthesia) Physical Status Classification Score of 3 or greater\]~* Eating disorders, especially binge eating~* Inability to walk 200 yards without assistance~* Known allergies to any of the device materials or accessories, i.e. silicone, methylene blue, corn starch~* Active drug or alcohol addiction within 12 months of enrollment~* Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood of requiring insulin treatment in the following 12 months~* Depressive disorder with total Beck Depression Inventory (BDI) score \> 16 points, and/or BDI affective subscale score \> 7 points at screening~* Ongoing treatment, or anticipated need for such treatment, with anticoagulants, known gastric irritants such as aspirin (ASA) or non-steroidal anti-inflammatory drugs (NSAIDs) or agents that can promote gastrointestinal bleeding, within 1 month prior to enrollment, or unwillingness to forego these medications during the study period~* Participation within 60 days of screening date in previous or ongoing clinical trial or current usage of an investigational drug or device~* Any use of an intragastric device prior to this study.~* Genetically caused obesity, such as Prader-Willi syndrome~* Any prior bariatric surgery or likely to undergo bariatric surgery during study follow-up period~* Concomitant use of, or unwillingness to avoid any use of, weight loss medications, weight loss supplements, weight loss herbal preparations and/or participation in any non-study-related organized weight loss program (commercial or medical) at any time during the study, including online or smart phone applications to track or modify food intake, exercise regimens or weight~* Chronic opiate use (\> 3 months continuous use) or likely need for opiate use during study participation~* Contraindication or allergy to, or unwillingness to use, proton pump inhibitor medication throughout study follow-up duration-Pregnancy, breast feeding, or intention of becoming pregnant during the study~* Any screening laboratory values outside of the normal range deemed clinically significant by the Investigator~* Anemia defined as either:~  1. Hemoglobin (Hgb) value for females of \< 11.0 g/dl, for males \< 12.0 g/dl~ 2. Abnormal red cell indices and iron deficiency~* Smoking cessation within 3 months of study entry or plans to quit smoking during the study~* Major surgery, open biopsy or significant traumatic injury within 3 months prior to enrollment.~* History of significant adverse experience with sedation or anesthesia~* Serious or uncontrolled psychiatric illness or disorder that could compromise patient understanding of or compliance with study procedures~* Any condition that, in the opinion of the Investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements, including:~  1. Inability or unwillingness to sign the patient informed consent document.~ 2. Inability to participate in all necessary study activities due to physical or mental limitations.~ 3. Inability or unwillingness to return for all required follow-up visits.~* Employees/family members of ReShape Medical® or any of its affiliates or contractors~* Employees/family members of the Investigator, sub-Investigators, or their medical office or practice, or surgical, bariatric or hospital organizations at which study procedures may be performed~* An immediate family member (by marriage or blood relationship) of another subject already enrolled in the REDUCE Pivotal Trial~Endoscopic exclusion criteria:~* Peptic ulcerations~* Clinically significant hiatal hernia (\> 3 cm)~* Patulous pyloric channel~* Erosive esophagitis~* Varices~* Angiectasias~* Barrett's esophagus~* Esophageal stricture~* Gastric mass~* Any other subject characteristic that would prevent the successful insertion of a ReShape Duo™ or that in the opinion of the Investigator preclude safe use of the ReShape Duo™

- Gender: ALL
- Minimum Age: 21 Years
- Maximum Age: 60 Years
- Healthy Volunteers: f

Study Arms:
- ReShape Duo Balloon (Type: ACTIVE_COMPARATOR): ReShape Duo Balloon
- Sham Comparator (Type: SHAM_COMPARATOR): Sham Comparator

Based on this trial design, predict the completion outcome and termination type (if applicable).