Over WeightNCT01753609
Safety and Performance Evaluation of Tulip Device in Healthy Overweight and Obese Volunteers
A study testing Tulip capsule in people with Over Weight and Obesity, run by Tulip Medical Ltd. at 1 site in Israel.
Trial summary
The study will assess the safety and performance of an intragastric auto-inflating and degradable balloon Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Over Weight, Obesity
- What is being tested?
- Tulip capsule
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2013to Jul 2013
- Phase
- Interventional
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 21 ≤ Age <65 years
- 30 < BMI ≤ 35 kg/m2
- Healthy without any medication;
- No history of weight reduction of more than 5% of total body weight in the past 6 months;
- Normal blood count and chemistry;
- Hemoglobin level over 11;
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- At least 3 bowel movements per week;
- Subject declares that he/she is able to go through gastroscopic examination;
- Subject is able and willing to give informed consent and follow protocol procedures.
Who cannot join
- Any history or evidence of significant cardiac, renal, neurologic, metabolic, pulmonary, gastrointestinal, hematologic abnormality, chronic hepatic disease or any other disease which in the judgment of the investigator would interfere with the study or confound the results;
- History or evidence of any active liver disease. (abnormal liver functions: >1.5 times upper limit);
- History or symptoms of thyroid disease which is not controlled by medication;
- Abnormal gastrointestinal findings: Diaphragmatic hernia > 3 cm; Active peptic ulcer; Erosive gastritis; Gastric outlet obstruction;
- Subject with IBD
- Significant swallowing disorders;
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- Past history of any gastrointestinal surgery (excluding uncomplicated appendectomy);
- Malabsorption disorders.
- Is taking medications that reduce gastric acidity
- Currently using pharmaceutical agents or food supplements for weight loss;
- History of or current eating disorder such as anorexia or bulimia or compulsory overeating.
- History of food Allergy;
- Subject with poor venous access;
- Is taking chronic aspirin or other non-steroidal anti-inflammatory agents, or other medications known to be gastric irritants;
- Have any coagulation problem and/or taking any anticoagulant medications;
- Evidence of current malignant disease;
- Have history of any acute disease (viral, bacterial, pain, accident) in the last 6 weeks.
- Female subject who are breastfeeding or have a positive pregnancy test at screening or at any time during the study;
- Inability to give written informed consent;
- History of alcohol or drug abuse within 6 months of screening;
- Mental disorders;
- Currently participating in an ongoing clinical study
- Any reasons making the patient a poor candidate in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Tel Aviv Sourasky Medical Center , Gastroenterology - Institute
Tel Aviv, 64239
Sigal Fishman, Dr., 972-3-6974469, sigalf@tlvmc.gov.il
Sara Pel, 972-3-6974469, sarap@tlvmc.gov.il
About this study
Official title: Safety and Performance Evaluation of TrimWeight Device - an Intragastric Auto-inflating & Degradable Balloon in a Swallow-able Capsule ("the Device"), for Enhancing Satiety and Satiation in Healthy Over Weight and Obese Volunteers
The study will assess the safety and performance of an intragastric auto-inflating and degradable balloon
Read the detailed description
The study will assess the safety and performance of an intragastric auto-inflating and degradable balloon, packed in a swallow-able capsule, in healthy subjects with 30 < BMI≤ 35.
- Conditions
- Over Weight, Obesity
- Being tested
- Tulip capsule
- Keywords
- Over weight, Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tulip capsuleDevice
swallowing Tulip capsule for up to 29 days
| Study group | Role | What they receive |
|---|---|---|
| Tulip capsule | Experimental | swallowing Tulip capsule for up to 29 days Receives: Device: Tulip capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with device related serious adverse events
Safety will be assessed descriptively by summarizing device related SAEs, gastroscopic examination, daily diary, vital sign measurements, physical examination and abdomen circumference.
Measured: 36 days
Secondary outcomes (2)
Patient assessment of capsule tolerability
Comfort and tolerability will be assessed by the patient and will be recorded in a daily diary. Tolerability evaluation will include: assessment of swallow ability, gastrointestinal comfort, defecation effort, appetite.
Measured: 36 days
Satisfying evacuation of the balloon from the stomach after oral intake
Number of subjects showing satisfying evacuation of the balloon from the stomach after oral intake by means of a gastroscopic examination
Measured: 36 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionMar 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Over WeightStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tulip Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sigal Fishman, Dr., Principal investigator, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753609
- Sponsor's protocol ID
- TULIP-PRT-002-05-B-CTIL
- Status last verified
- Dec 2012
- First submitted
- 17 Dec 2012
- Last updated
- 20 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance Evaluation of TrimWeight Device - an Intragastric Auto-inflating & Degradable Balloon in a Swallow-able Capsule ("the Device"), for Enhancing Satiety and Satiation in Healthy Over Weight and Obese Volunteers
- ClinicalTrials.gov ID
- NCT01753609
- Acronym / sponsor ID
- TULIP-PRT-002-05-B-CTIL
- Conditions
- Over Weight, Obesity
- Keywords
- Over weight, Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Tulip Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 20 Dec 2012 (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.
The study will assess the safety and performance of an intragastric auto-inflating and degradable balloon
Detailed description
The study will assess the safety and performance of an intragastric auto-inflating and degradable balloon, packed in a swallow-able capsule, in healthy subjects with 30 < BMI≤ 35.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tulip capsule | Experimental | Device: Tulip capsuleswallowing Tulip capsule for up to 29 days |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 21 ≤ Age <65 years
- 30 < BMI ≤ 35 kg/m2
- Healthy without any medication;
- No history of weight reduction of more than 5% of total body weight in the past 6 months;
- Normal blood count and chemistry;
Key exclusion criteria (23 listed)
- Any history or evidence of significant cardiac, renal, neurologic, metabolic, pulmonary, gastrointestinal, hematologic abnormality, chronic hepatic disease or any other disease which in the judgment of the investigator would interfere with the study or confound the results;
- History or evidence of any active liver disease. (abnormal liver functions: >1.5 times upper limit);
- History or symptoms of thyroid disease which is not controlled by medication;
- Abnormal gastrointestinal findings: Diaphragmatic hernia > 3 cm; Active peptic ulcer; Erosive gastritis; Gastric outlet obstruction;
- Subject with IBD
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 |
|---|---|---|
| Tulip capsuleswallowing Tulip capsule for up to 29 days | Device | Tulip capsule |
Primary outcome
Number of subjects with device related serious adverse events
Time frame: 36 days
Safety will be assessed descriptively by summarizing device related SAEs, gastroscopic examination, daily diary, vital sign measurements, physical examination and abdomen circumference.
2 secondary outcomes
Patient assessment of capsule tolerability
Time frame: 36 days
Satisfying evacuation of the balloon from the stomach after oral intake
Time frame: 36 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2012.
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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.
Sigal Fishman, Dr. principal investigator
Tel Aviv Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tulip capsule in people with Over Weight and Obesity, run by Tulip Medical Ltd. at 1 site in Israel.
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 9 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 20 Dec 2012. 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 Israel. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sigal Fishman, Dr. (972-3-6974469, sigalf@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with device related serious adverse events (time frame: 36 days). 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 20 Dec 2012.