Plain English Summary
Background and study aims
The SatiSphere is a new device for the treatment of obesity. It is implanted into the stomach and duodenum (the first part of the small intestine) through an endoscope (a long, thin, flexible tube) under general anaesthetic. It is designed to help reduce food intake by slowing the passage of food through the duodenum, tricking the body into sensing more food intake than has occurred. The aim of this study is to provide information about the feasibility, short-term effectiveness, and safety of the SatiSphere device.
Who can participate?
Overweight people (BMI between 30 and 50), aged 18-60
What does the study involve?
Participants are randomly allocated to one of two groups. One group are implanted with the SatiSphere, and the other group are treated with diet and exercise only. The effectiveness of the SatiSphere is assessed in terms of weight loss in the SatiSphere group compared to the diet and exercise group after 3 months. Safety is assessed as the number of serious device or procedure related adverse events (side effects) over the study period of 3 months. Patients are also asked for any positive or negative symptoms possibly related to the SatiSphere device at monthly intervals.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Universitätsklinikum Hamburg-Eppendorf (Germany)
When is the study starting and how long is it expected to run for?
October 2011 to December 2012
Who is funding the study?
Endosphere Inc (USA)
Who is the main contact?
Prof. Thomas Rösch
t.roesch@uke.de
Study website
Contact information
Type
Scientific
Contact name
Prof Thomas Rösch
ORCID ID
Contact details
Universitätsklinikum Hamburg-Eppendorf
Martinistr. 52
Hamburg
20246
Germany
-
t.roesch@uke.de
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
ENDO 2009-003
Study information
Scientific title
A multicenter study to investigate the efficacy and safety of the Satisphere™ duodenal insert in overweight patients
Acronym
Study hypothesis
1. To determine weight-loss compared to a control group
2. To evaluate device safety
Ethics approval(s)
Freiburg Ethics Commission, 07/02/2010, ref: 09/2925
Study design
Open randomised trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Obesity
Intervention
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
Intervention type
Other
Primary outcome measure
Excess weight loss (EWL) after 3 months of therapy
Secondary outcome measures
1. Proportion of overweight patients who achieve a 10% or greater excess weight loss (EWL) after 3 months of therapy
2. Total weight (kg) loss after 3 months of therapy
3. Frequency and severity of all (serious and non-serious) device/procedure related adverse events over 3 months
4. Frequency and severity of all non-device/non-procedure related adverse events over 3 months
5. Tolerance of the SatiSphereTM Duodenal Insert, indicated by premature removal of the SatiSphere due to excess nausea or pain
6. Frequency of migration of the SatiSphereTM Duodenal Insert between 72 hours and 3 months post insertion
7. Effect on tissue health of the SatiSphereTM Duodenal Insert over a 3 month period
Overall study start date
01/10/2011
Overall study end date
01/12/2012
Reason abandoned (if study stopped)
Eligibility
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
2.3. Condom
2.4. Diaphragm
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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Upper age limit
60 Years
Sex
Both
Target number of participants
60
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
01/10/2011
Recruitment end date
01/12/2012
Locations
Countries of recruitment
Germany
Study participating centre
Universitätsklinikum Hamburg-Eppendorf
Hamburg
20246
Germany
Sponsor information
Organisation
Endosphere Inc (USA)
Sponsor details
4449 Easton Way
Columbus
43219
United States of America
-
jim@endosphereinc.com
Sponsor type
Industry
Website
ROR
Funders
Funder type
Industry
Funder name
Endosphere Inc (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|