Plain English Summary
Lay summary under review 3
Prof Thomas Rösch
A multicenter study to investigate the efficacy and safety of the Satisphere™ duodenal insert in overweight patients
1. To determine weight-loss compared to a control group
2. To evaluate device safety
Freiburg Ehtics Commission, 07 February 2010, ref: 09/2925
Open randomised trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Endoscopic Treatment with a new device ("Satisphere")
Sixty patients will be enrolled in 2 sites, twenty of whom will be randomized to a diet-only control group.
Recruitment is expected to start in April 2010. The clinical phase of this study will take approximately 8 months.
The SatiSphere device is a self-anchoring, conformationally stabilized device. The device is endoscopically delivered, easily removable and is preformed to take the shape of the duodenum. The SatiSphere device is designed to self-anchor in humans by using the following features of the human anatomy:
1. The general C shape of the duodenum
2. The two fixed points of the duodenum in the first portion where the duodenum passes through the peritoneal wall, and in the fourth portion where the duodenum is immobilized by the ligament of Treitz..
The SatiSphere Device is designed to help reduce food intake by slowing the passage of food through the duodenum, tricking the body into sensing more caloric intake than has occurred. EndoSphere is focused on using the bodys endocrine system to signal satiety early, and to down-regulate liver glucose production.
Current evidence supports a role for gastrointestinal peptides as regulators of satiety.
Screening will consist of:
1. Anthropometric and clinical parameters: Body weight, height, BMI and physical exam,
2. Medical history: Complete medical history will include evaluation of past or present cardiovascular, respiratory, gastrointestinal, renal, hepatic, neurological, endocrine, lymphatic, hematological, immunological, dermatological, psychiatric, genitourinary, and surgical history or any other diseases or disorders.
Any currently active medication will be recorded.
3. Vital signs (Blood pressure and pulse rate: sitting after 3 minutes rest, and body temperature.
4. 12 lead ECG
Primary outcome measures
To demonstrate the efficacy of the SatiSphereTM Duodenal Insert in promoting excess weight loss (EWL) in overweight patients compared to a diet and exercise control group after 3 months of therapy.
Secondary outcome measures
1. To evaluate the efficacy of the SatiSphereTM Duodenal Insert by comparing the proportion of overweight patients who achieve a 10% or greater excess weight loss (EWL) in the SatiSphere group to patients in a diet and exercise control group after 3 months of therapy.
2. To evaluate the efficacy of the SatiSphereTM Duodenal Insert by comparing total weight (kg) loss in overweight patients treated with the SatiSphere to overweight patients in a diet and exercise control group after 3 months of therapy.
3. To evaluate the safety of the SatiSphereTM Duodenal Insert by characterizing the frequency and severity of all (serious and non-serious) device/procedure related adverse events over 3 months in overweight patients treated with the SatiSphere device.
4. To evaluate the safety of the SatiSphereTM Duodenal Insert by characterizing the frequency and severity of all non-device/non-procedure related adverse events over 3 months in overweight patients treated with the SatiSphere device and those in a diet and exercise control group.
5. To evaluate tolerance of the SatiSphereTM Duodenal Insert among overweight patients as indicated by premature removal of the SatiSphere due to excess nausea or pain.
6. To evaluate the frequency of migration of the SatiSphereTM Duodenal Insert among overweight patients between 72 hours and 3 months post insertion.
7. To evaluate the effect on tissue health of the SatiSphereTM Duodenal Insert among overweight patients over a 3 month period.
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Male and Female aged 18-60 years
2. Men or non-pregnant women (only women who are post-menopausal, surgically sterile or practicing a reliable contraception such as:
2.1. Hormonal [oral] contraception
2.2. Intrauterine device
3. BMIs between 30 and 50
4. Patients who are healthy as determined by pre-study medical history, physical examination, 12 lead-ECG
5. Patients who are able to understand the protocol
6. Patients who have been informed of the nature of the study and have agreed to its provisions and given written informed consent as approved by the Local Research Ethics Committee or the physician of the respective clinical site.
Target number of participants
Participant exclusion criteria
1. Classified in anesthesia risk group, ASA Class 4-5
2. Crohns disease or Ulcerative Colitis (inflammatory bowel disease)
3. Endocrine or other disorders that can cause obesity
4. Pregnancy (a urinary test for pregnancy must be performed in female patients before inclusion in the study)
5. Women who may be attempting to become pregnant
6. Type 2 diabetes defined as fasting plasma glucose (FPG) level of >126 mg/dL and a HbA1c level > 6.5% (or at least 1 percent above the reference laboratory's upper range of normal). NB: the presence of hyperlipidemia (hypercholesterolemia, hypertrigyliceridemia) is not an exclusion criterion)
7. Present alcohol or drug abuse or a smoker
8. Previous bariatric (including lap-band) or gastrointestinal surgery
9. History of bleeding diathesis or coagulopathy or will refuse blood transfusions;
10. Patients at need of anticoagulation therapy, Aspirin, Non-Steroidal Anti-Inflammatory Drugs (NSAIDS), or steroids
11. Experienced a hematologically significant gastrointestinal (GI) bleed within the past six months;
12. Has other medical illness (i.e., congestive heart failure) that may cause the patient to be non-compliant with the protocol, confound the data interpretation or is associated with limited life-expectancy (i.e., less than one year)
13. Simultaneously participating in another device or drug study, or who has participated in any clinical trial involving an experimental device within 6 months or experimental drug or device within 30 days of study entry
14. Significant depression or borderline personality disorder as indicated by medical record and/or clinical interview
15. Active suicide ideation and/or History of multiple suicide attempts within the past 5 years
16. Active psychosis present (current evidence of active psychosis and/or mental health hospitalization for psychosis in past 1 year).
17. Patients known to be binge eaters or with other eating disorders.
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Endosphere Inc (USA)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting