The IGBallon (R) - for Use in the Treatment of Obesity

Intra-gastric Balloon (IGBalloon(R)) for Use in the Treatment of Obesity - a Pilot Study

This study is a prospective, non-randomized, open-label, single-center study.

The aim of this study is to assess the safety of the IGballoon in the human body. The effectiveness of the IGBalloon in relation to weight loss behaviour of the human body will also be investigated. This study will involve 20 participants who will be divided into two groups:

1. Monitoring group with 5 participants who swallow an IGBalloon. After four weeks, safety will be tested. Up to four additional IGBalloons may be ingested, if necessary, over the following eight weeks.
2. Treatment group of 15 participants receiving up to 5 IGBalloons over a period of 8 weeks as required. This group will be evaluated for efficiency of the IGBalloon.

Various examinations, such as clinical examinations, blood tests, and gastroscopies will be carried out at certain follow-up points. Patients also receive dietary support for the entire duration of the study.

The study will be divided into a screening phase and treatment period. Informed consent must be obtained prior to conducting any screening or other study-related procedures or evaluations.

The screening phase will take place 28 days prior to the administration/ingestion of the first device. Participants will be evaluated against the protocol-specific inclusion and exclusion criteria to determine their eligibility for participation in the study. An initial five (5) participants meeting eligibility requirements will ingest a single IGBalloon, undergo an immediate endoscopy to assess device inflation and initial condition of the gastric mucosa and will be followed-up at 1, 2, 4, 6, and 8 weeks.

At the 2 week follow-up appointment, a second IGBalloon may be ingested if there is no decrease in weight and/or increase in satiety.

At the 4 week follow-up appointment, again, an additional IGBalloon may be ingested if there is no decrease in weight and/or increase in satiety.

At the 6 week follow-up appointment, an additional IGBalloon may be ingested if there is still no decrease in weight and/or increase in satiety.

At the 8 week follow-up, an additional device (maximum of 5) for the same reasons mentioned above.

The initial 5 sentinel patients will undergo an endoscopy to observe balloon inflation and condition of the gastric mucosa. No more than five (5) IGBalloons may be ingested by a single participant. In the event that no significant changes have occurred to the gastric mucosa and no other unanticipated serious adverse events have occurred in the initial five participants, a further 15 participants will begin the treatment and follow-up regimen. This larger cohort of participants will not undergo the endoscopy procedure at the 8 week follow-up but follow the same treatment and follow-up regimen in all other aspects.

Further follow-up consultations will occur at 12, 16, 20, 24 and 36 weeks following the ingestion of the first IGBalloon. A final 52-week follow-up will include an additional endoscopy procedure on all participants. Following the 52 week follow-up of all participants, the study will be deemed to have been completed. Participants may elect to keep the IGBalloons in place, or have them removed at the 52 week endoscopy procedure. Those participants electing to keep the balloons in place will be monitored on an ongoing basis. Should participants require follow-up for adverse events or require any additional clinical laboratory or physical examinations, they may return to the clinic as deemed appropriate by the physician.

Inclusion Criteria:

• Body Mass Index (BMI) greater than 35 or greater than 30 with comorbidities (type 2 diabetes, dyslipidemia, hypertension, obstructive sleep apnea, osteoarthritis, or coronary heart disease).
• Male or female participants aged between 18-70 years and representative of the general population.
• Availability for the entire study period, and willingness to adhere to protocol requirements as evidenced by giving signed informed consent.
• Failure at previous attempts at weight loss through diet, exercise, and/or behavior modification.

Exclusion Criteria:

• Severely obese (BMI > 45) or >120 kg.
• Previous gastric surgery affecting the esophagus, stomach, or pylorus that would interfere with ingestion or placement of the IGBalloon.
• Debilitating comorbidities preventing surgery.
• Inflammatory disease of the gastrointestinal (GI) tract.
• Upper-GI bleeding conditions.
• History of gastrointestinal ulcers or bleeding.
• Existing gallbladder disease.
• Positive breath test for the presence of H. pylori infection.
• Gastro-esophageal reflux resistant to proton pump inhibitors.
• Previously diagnosed with Cushing's disease and/or hypothyroidism.
• Malignant disease.
• Likely to require abdominal surgery during the study period.
• Upper-GI abnormalities or anatomical variants likely to interfere with the study procedure.
• Symptomatic documented hiatal hernia.
• Insulin-dependent diabetes mellitus.
• Life expectancy of less than 2 years.
• Participation in another clinical trial investigating a therapeutic device or medicine.
• Major prior or present psychological or psychiatric disorder (including a history of drug and/or alcohol addiction, severe depression, Electroconvulsive Therapy (ECT) treatment - current or recent.)
• Inability to tolerate blood draws.
• Inability or unwillingness to swallow large items after coaching in swallowing technique.
• If female, lactating or positive pregnancy test at screening or before each of the treatment periods.
• If female and of child-bearing potential, unwillingness to abstain from sexual intercourse or use a medically acceptable method of contraception from 14 days before the study and throughout the entire study period.

Acceptable methods of contraception:

1. Hormonal contraceptive, if used for at least 3 months prior to study.

2. Intrauterine device (IUD).

3. Condom and spermicide.

4. Diaphragm and spermicide.

5. Abstinence.

6. Surgical sterilization of either partner.

   • Previously defined non-compliance with prescribed medical care.
   • Identified eating disorder likely to significantly increase risk of complication.
   • Prior enrolment in this study.