Obesity, Non-morbidPhase 1SENSATENCT00753350
METHOD (Minimally Invasive, Endoscopically-delivered, Tolerable by Human Individuals, Non-morbid Obesity Device) Study
A Phase 1 study testing Sensate™ anchored gastric device in people with Obesity, Non-morbid, run by Sensate LLC at 1 site in Germany.
Trial summary
This will be an open label, single-center, feasibility study comprised of two sequential cohorts( cohort 1: 2 participants; cohort 2: 8 participants). This study will be conducted in generally healthy participants aged 25 to 55 years with non-morbid obesity and a pre-screening body mass index between 35 and 40. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Obesity, Non-morbid
- What is being tested?
- Sensate™ anchored gastric device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2008to Sep 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female participants, 25 years of age or older and 55 years of age or younger at the time of the first screening visit.
- BMI (Body Mass Index) prior to the first screening visit between 35 - 40 kg/m2.
- General good health confirmed by medical history, physical examination, medication use in the 30 days prior to the baseline visit, and clinical chemistry and hematology lab test results.
- For women of childbearing potential: negative pregnancy test and willingness to use effective contraception during the entire study period.
- Signed informed consent to participate in the study.
- Ability of the participant to comply with all the requirements of the study and participate in all the intensive activities of the study throughout the study period.
Who cannot join
- Any contraindication to undergoing endoscopic and/or laparoscopic procedures.
- Known gastric motility disorder and/or history of chronic constipation problems.
- Known peptic ulcer and/or previous gastrointestinal antrum and/or pyloric surgery (open or laparoscopic) and/or structural abnormalities of the gastrointestinal tract (drop out criteria).
- History of chronic intestinal diseases or disorders.
- Prior obesity prevention surgical procedure (intra-gastric balloon, Lap band™ procedure, Bariatric surgery or others).
- Significant weight fluctuations (greater than ±5 kg) within the period of three months prior to first screening visit.
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- Participants with significant eating pattern alterations according to participant interview.
- Current systemic intake of laxatives, steroids, non-steroidal anti-inflammatory medications, anticoagulants within 30 days prior to the screening visit and for the entire study duration.
- Participants who have a clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation. Such conditions include significant gastrointestinal, cardiovascular, vascular disease, pulmonary/respiratory, hepatic impairment, renal, metabolic diseases, endocrinological, neurological, immune-deficiency, hematopoietic disease, or malignancies as determined by medical history, physical examination, or laboratory tests.
- Participants with any clinically significant abnormality upon physical examination or in the clinical laboratory test values such as abnormal blood test or abnormal blood coagulation test results prior to the baseline visit.
- Participants with any acute medical situation (e.g. severe febrile illness) or any uncontrollable infection, which is considered of significant by the Principal Investigator.
- Participants who have participated in another clinical trial of any kind within three months prior to the screening visit.
- Organ allograft.
- For female participants: planned pregnancy within 6 months from study start, active pregnancy, or breast-feeding.
- For male participants: intention to have a child within 6 months from the baseline visit.
- Any form of substance abuse (including drug or alcohol abuse), psychiatric disorder, or any chronic condition susceptible, in the opinion of the investigator, of interfering with the conduct of the study.
- Participants who are likely to be non-compliant or uncooperative during the study.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Johannes Gutenberg University, I. Med. Klinik
Mainz, Rhineland-Palatinate, 55131
About this study
Official title: An Open-label, Single-center, Feasibility Study Designed to Evaluate the Safety and Tolerability of Sensate™ Anchored Gastric Device in Subjects With Non-morbid Obesity
This will be an open label, single-center, feasibility study comprised of two sequential cohorts( cohort 1: 2 participants; cohort 2: 8 participants).
This study will be conducted in generally healthy participants aged 25 to 55 years with non-morbid obesity and a pre-screening body mass index between 35 and 40.
Participants will undergo screening to determine their health status and their eligibility to participate in the study. Eligible patients will undergo an endoscopic device delivery procedure during which the device will be anchored in the inner stomach wall at the distal anterior antrum. Physical examination and/or endoscopic safety evaluations will be conducted on day 14 and 28. The device and its anchor will be completely removed endoscopically after 8 weeks. The participants will be followed-up for safety evaluation for an additional period of 2 weeks.
Read the detailed description
Effective and safe methods are required to achieve substantial and long-lasting weight-loss with minimal and preferably no impact on the non-morbid obese individuals' pre-procedure lifestyle. The current available treatments for obesity in general and non-morbid obesity in particular, are, for the most part, ineffective in the long run and are associated with material adverse events and potentially lethal complications.
Sensate™, is an endoscopically-delivered, inner-stomach-wall-anchored, low-profile device (practically the exact size and shape of the famous Given Imaging PillCam™ swallowable device), which is advantageous in comparison to both open and minimally invasive surgical methods for treating obesity. The reason for that is because of the simple endoscopic delivery, inner-antrum-wall-anchoring and removal procedures are safe, minimally-invasive, requiring minimal participant sedation (not deep anesthesia), not requiring unique gastroenterologist skills, and can be done in an outpatient clinic setting just like in the hospital setting. Moreover, Sensate™ is designed to modestly reduce food consumption concurrently with the generation of greater satiety, and thus maintain balanced and healthier weight loss over a long period of time without mandating complementary radical lifestyle changes and nutritional changes which have been proven to be very hard and impractical on the obese individual.
This study will be the first study in humans, and it is focused on examining and validating the safety, tolerability and preliminary efficacy of Sensate™ in humans.
The Sensate™ study is comprised of two sequential cohorts of generally healthy patients with non-morbid obesity, with two participants in the first cohort and eight subjects in the second cohort. The first cohort is starting with just 2 subjects, in order to validate the absolute safety of the device and its delivery before additional subjects are being recruited. The sample size is the minimal one required to collect safety, tolerability and preliminary efficacy data. Participants will undergo screening to determine their health status and their eligibility to participate in the study. Screening examinations include medical history, physical examination, vital signs, weight measurement and laboratory assessments. Eligible patients will undergo an endoscopic device delivery procedure during which the device will be anchored in the inner stomach wall at the distal anterior antrum. Patients will be requested to complete a detail daily diary based on visual analogue scale (VAS) to record their eating sensations during and after each meal throughout the study. Physical examination, recording of adverse events and weight measurements will be conducted on day 14 and 28. In addition, phone calls are made every week during the study period to ask the patient about any health alterations. Endoscopic safety evaluation to validate that the device is anchored properly with no safety issues will be performed on Days 14 and 28 in the first two subjects and at day 28 for the remaining eight subjects. The device and its anchor will be completely removed endoscopically after 8 weeks. The participants will be followed-up for safety evaluation for an additional period of 2 weeks. Safety evaluations include physical examination, vital signs, adverse events and laboratory assessments.
- Conditions
- Obesity, Non-morbid
- Being tested
- Sensate™ anchored gastric device
- Keywords
- obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensate™ anchored gastric deviceDevice
Delivery/anchoring of the Sensate™ device in the stomach. Withdrawal of the Sensate™ device and its anchoring components after 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Sensate™ anti-Obesity device Receives: Device: Sensate™ anchored gastric device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (subjective participant reporting or documentation).
Measured: 12 weeks
Secondary outcomes (1)
Vital signs. Laboratory tests. Pathological findings in physical Examination and in endoscopic examination of stomach. Concomitant medication use. Body weight measurements. Improved VAS-based score.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, Non-morbidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sensate LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Johannes Gutenberg University Mainz
- Responsible party
- Sponsor
- Investigators
- Ralf Kiesslich, Univ.-Prof. Dr. med., Principal investigator, Johannes Gutenberg University Mainz, I. Med. Klinik und Poliklinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00753350
- Sponsor's protocol ID
- SN-101-MZ
- Acronym
- SENSATE
- Status last verified
- Mar 2013
- First submitted
- 15 Sep 2008
- Last updated
- 4 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-center, Feasibility Study Designed to Evaluate the Safety and Tolerability of Sensate™ Anchored Gastric Device in Subjects With Non-morbid Obesity
- ClinicalTrials.gov ID
- NCT00753350
- Acronym / sponsor ID
- SENSATE / SN-101-MZ
- Conditions
- Obesity, Non-morbid
- Keywords
- obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Sensate LLCIndustry (pharma, biotech, devices)
- Collaborators
- Johannes Gutenberg University Mainz
- Study start
- Sep 2008
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 16 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be an open label, single-center, feasibility study comprised of two sequential cohorts( cohort 1: 2 participants; cohort 2: 8 participants).
This study will be conducted in generally healthy participants aged 25 to 55 years with non-morbid obesity and a pre-screening body mass index between 35 and 40.
Participants will undergo screening to determine their health status and their eligibility to participate in the study. Eligible patients will undergo an endoscopic device delivery procedure during which the device will be anchored in the inner stomach wall at the distal anterior antrum. Physical examination and/or endoscopic safety evaluations will be conducted on day 14 and 28. The device and its anchor will be completely removed endoscopically after 8 weeks. The participants will be followed-up for safety evaluation for an additional period of 2 weeks.
Detailed description
Effective and safe methods are required to achieve substantial and long-lasting weight-loss with minimal and preferably no impact on the non-morbid obese individuals' pre-procedure lifestyle. The current available treatments for obesity in general and non-morbid obesity in particular, are, for the most part, ineffective in the long run and are associated with material adverse events and potentially lethal complications.
Sensate™, is an endoscopically-delivered, inner-stomach-wall-anchored, low-profile device (practically the exact size and shape of the famous Given Imaging PillCam™ swallowable device), which is advantageous in comparison to both open and minimally invasive surgical methods for treating obesity. The reason for that is because of the simple endoscopic delivery, inner-antrum-wall-anchoring and removal procedures are safe, minimally-invasive, requiring minimal participant sedation (not deep anesthesia), not requiring unique gastroenterologist skills, and can be done in an outpatient clinic setting just like in the hospital setting. Moreover, Sensate™ is designed to modestly reduce food consumption concurrently with the generation of greater satiety, and thus maintain balanced and healthier weight loss over a long period of time without mandating complementary radical lifestyle changes and nutritional changes which have been proven to be very hard and impractical on the obese individual.
This study will be the first study in humans, and it is focused on examining and validating the safety, tolerability and preliminary efficacy of Sensate™ in humans.
The Sensate™ study is comprised of two sequential cohorts of generally healthy patients with non-morbid obesity, with two participants in the first cohort and eight subjects in the second cohort. The first cohort is starting with just 2 subjects, in order to validate the absolute safety of the device and its delivery before additional subjects are being recruited. The sample size is the minimal one required to collect safety, tolerability and preliminary efficacy data. Participants will undergo screening to determine their health status and their eligibility to participate in the study. Screening examinations include medical history, physical examination, vital signs, weight measurement and laboratory assessments. Eligible patients will undergo an endoscopic device delivery procedure during which the device will be anchored in the inner stomach wall at the distal anterior antrum. Patients will be requested to complete a detail daily diary based on visual analogue scale (VAS) to record their eating sensations during and after each meal throughout the study. Physical examination, recording of adverse events and weight measurements will be conducted on day 14 and 28. In addition, phone calls are made every week during the study period to ask the patient about any health alterations. Endoscopic safety evaluation to validate that the device is anchored properly with no safety issues will be performed on Days 14 and 28 in the first two subjects and at day 28 for the remaining eight subjects. The device and its anchor will be completely removed endoscopically after 8 weeks. The participants will be followed-up for safety evaluation for an additional period of 2 weeks. Safety evaluations include physical examination, vital signs, adverse events and laboratory assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Sensate™ anchored gastric deviceSensate™ anti-Obesity device |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female participants, 25 years of age or older and 55 years of age or younger at the time of the first screening visit.
- BMI (Body Mass Index) prior to the first screening visit between 35 - 40 kg/m2.
- General good health confirmed by medical history, physical examination, medication use in the 30 days prior to the baseline visit, and clinical chemistry and hematology lab test results.
- For women of childbearing potential: negative pregnancy test and willingness to use effective contraception during the entire study period.
- Signed informed consent to participate in the study.
Key exclusion criteria (17 listed)
- Any contraindication to undergoing endoscopic and/or laparoscopic procedures.
- Known gastric motility disorder and/or history of chronic constipation problems.
- Known peptic ulcer and/or previous gastrointestinal antrum and/or pyloric surgery (open or laparoscopic) and/or structural abnormalities of the gastrointestinal tract (drop out criteria).
- History of chronic intestinal diseases or disorders.
- Prior obesity prevention surgical procedure (intra-gastric balloon, Lap band™ procedure, Bariatric surgery or others).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensate™ anchored gastric deviceDelivery/anchoring of the Sensate™ device in the stomach. Withdrawal of the Sensate™ device and its anchoring components after 8 weeks. | Device | 1 |
Primary outcome
Adverse Events (subjective participant reporting or documentation).
Time frame: 12 weeks
1 secondary outcome
Vital signs. Laboratory tests. Pathological findings in physical Examination and in endoscopic examination of stomach. Concomitant medication use. Body weight measurements. Improved VAS-based score.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralf Kiesslich, Univ.-Prof. Dr. med. principal investigator
Johannes Gutenberg University Mainz, I. Med. Klinik und Poliklinik
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sensate™ anchored gastric device in people with Obesity, Non-morbid, run by Sensate LLC at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (subjective participant reporting or documentation). (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2013.