The BALLOON- (BALLOon Treatment for Obesity in Norway) Pilot Study
The BALLOON- (BALLOon Treatment for Obesity in Norway) Pilot Study
This protocol describes a feasibility pilot study preceding a randomized clinical study that
 aims at comparing the Elipse intragastric Balloon system to other invasive obesity
 techiniques.

 The current pilot study is investigating the feasibility and efficacy of the Elipse Balloon
 system in 20 patients in Norway.
The primary aims of the pilot study are to streamline the infrastructure, machinery, and
 clinical experience with the balloon before the start of the randomized trial. The inclusion
 and exclusion criteria, and measurement points will be similar for the two studies.

 The primary endpoints of the pilot study are to ascertain the feasibility of

 1. Patient recruitment and informed consent process

 2. Balloon insertion procedure

 3. Follow-up of patients for the period of balloon therapy (one balloon)

 4. Data gathering, data management, and endpoint evaluation

 5. Adverse event evaluation of balloon insertion and therapy Secondary endpoints are weight
 loss, HBA1c

 Eligible Patients Eligible patients are adults who have been referred for obesity treatment
 to one of the participating obesity centres and meet all of the inclusion criteria and none
 of the exclusion criteria.

 Inclusion criteria

 1. adults 18 year or older with BMI ≥30 and ≤40 kg/m2, and a diagnosis of type 2 diabetes.

 Feasibility of the intervention will be assesssed by the investigators. Subjects will be
 carefully monitored during the study for possible adverse events (AEs) and will be advised to
 contact the study investigator in case of symptoms of possible adverse events.. During each
 clinical follow-up visit, the investigator will determine AE occurrences. Each adverse event
 is considered to be either anticipated or unanticipated as described below.

 An AE is any adverse change from the subject's baseline (pre-treatment) condition, including
 a concurrent illness, occurring during the course of the study whether or not considered
 related to the study intervention (balloon or surgery). Therefore, an AE can be any
 unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or
 disease temporally associated with the study treatment, whether or not related to the
 procedure.

 All adverse events are described by the local study investigator using the electronic patient
 record system at the participating site. Adverse events will also be collected once yearly
 through searches in local and national patient registries (hospital discharge and diagnosis
 registry, Norwegian cause-of-death registry, Norwegian cancer registry).

 AEs are categorized as serious or non-serious. Serious Adverse Event (SAE) are those leading
 to

 -  unplanned medical or surgical intervention

 -  unplanned hospitalization (including emergency department visit)

 -  prolonged duration of planned hospitalization (>24hrs)

 -  life threatening illness or injury

 -  permanent impairment of a body structure or a body function

 -  Death Planned hospitalization for a pre-existing condition, or a procedure required by
 the protocol, without serious deterioration in health, is not considered a serious
 adverse event.

 Non-Serious Adverse Events:

 Adverse events that do not meet the definition of SAEs.

 AE evaluation Each reported SAE is reviewed by an adverse event evaluation committee. The
 committee consist of three individuals with a medical background relevant for the trial and
 its interventions. The committee is not blinded to treatment arm as this is not feasible
 given the nature of the trial interventions and the expected grade of details to review to
 make a decision. Each member of the AE evaluation committee reviews each case independently.
 Agreement of whether the SAE is due to the intervention or not (yes, no, An SAE report is
 submitted to the PIs and the company one time each year during the course of the trial.

 Participants will be examined by the study investigators 1 to 3 weeks prior to treatment
 start (baseline visit), and at weeks 4, 8, 12, 16, 26 and 52 after treatment start.

 At the baseline visit, demographic data and medical history is assessed.

 All visits include a clinical examination with measurements of body weight, anthropometric
 measures and blood pressure, laboratory analyses, a registration of supplementation and
 prescription and over-the-counter drug use, and registration of complications and side
 effects.

 Body weight and composition will be measured with patients wearing light clothing and no
 shoes using bioelectrical impedance analysis. Anthropometric measures will be recorded with
 patients in an upright position. Height will be measured using wall mounted stadiometers;
 waist circumference (WC) will be measured at the point midway between the lowest rib margin
 and the iliac crest. Height and circumferences will be measured to nearest 0.5 cm and weight
 to the nearest 0.1 kg.

 The following laboratory analysis will be performed: hemoglobin; white blood cell count;
 platelet count; international normalized ratio; C-reactive protein; blood glucose, HbA1c;
 insulin, C-peptide; anti-GAD; anti-IA2; sodium; potassium; phosphate; chloride; magnesium;
 serum iron; ferritin; transferrin; calcium; 1,25 dihydroxyvitamin D; 25 hydroxyvitamin D;
 parathyroid hormone; thiamine; B12; folate; creatinine; bilirubin; albumin; total protein;
 alanine aminotransferase; aspartate aminotransferase; alkaline phosphatase A; gamma-glutamyl
 transpeptidase; amylase; lactate dehydrogenase; triglycerides; total cholesterol; HDL
 cholesterol; LDL cholesterol; unbound thyroxine; thyroid stimulating hormone;
Inclusion Criteria:

 -  adults 18 year or older with BMI ≥30 and ≤40 kg/m2, and a diagnosis of type 2
 diabetes.

 Exclusion Criteria:

 1. Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery
 disease

 2. Previous bariatric or gastric surgery

 3. History of chronic or acute pancreatitis

 4. History of small bowel obstructions

 5. History of open abdominal and/or pelvic surgery EXCLUDING open appendectomy with a
 right lower quadrant incision.

 6. Thyroid or adrenal disease not controlled with medication

 7. History of/or signs and/or symptoms of esophageal, gastric, or duodenal disease such
 as dysphagia and/or painful swallowing, hiatal hernias >5 centimeter, paraesophageal
 hernias, chronic or acute inflammation, cancer, varices, diverticula, gastroparesis,
 ulcers, stricture/stenosis, or achalasia

 8. Specific diagnosed genetic or hormonal cause for obesity such as Prader-Willi syndrome

 9. Severe coagulopathy, hepatic insufficiency or cirrhosis

 10. Unable or unwilling to discontinue use of aspirin and/or non-steroidal
 anti-inflammatory agents (NSAIDs) at least 14 days prior to Elipse deployment and
 continuing for 14 days after Elipse excretion

 11. Anemia defined as either Hgb <11 g/dL for females and <12 g/dL for males

 12. Inability to walk 200 meters without assistance

 13. Eating disorders including night eating syndrome (NES), bulimia, or binge eating
 disorder

 14. Current or history of illicit drug use or excessive alcohol use

 15. Currently taking the following medications (within 30 days prior to enrolment) and/or
 anticipated need for these medications during the study: Systemic corticosteroids;
 anticoagulants (e.g. warfarin, dabigatran) or anti-platelet therapy; narcotics or
 opiates; anti-seizure medication (e.g. clonazepam, phenytoin)

 16. Serum autoantibodies against glutamic acid decarboxylase (GAD) or tyrosine phosphatase
 (IA2) (MODY or type 1 diabetes)

 17. Any specified conditions that, in the opinion of the investigator, may render the
 subject unable to complete the study without a likely fatal outcome, or lead to
 difficulties for subject compliance with study requirements, or could confound study
 data.

 18. Women in childbearing age must document a negative pregnancy test. Women must not be
 breast-feeding at the time of treatment.