Safety and Performance Evaluation of Tulip Device in Healthy Overweight and Obese Volunteers

Obesity Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01753609
• Other study ID #: TULIP-PRT-002-05-B-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: December 17, 2012
• Last updated: December 17, 2012
• Start date: January 2013
• Est. completion date: July 2013

Study information

• Verified date: December 2012
• Source: Tulip Medical Ltd.
• Contact: Sigal Fishman, Dr.
• Phone: 972-3-6974469
• Email: sigalf[@]tlvmc.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The study will assess the safety and performance of an intragastric auto-inflating and degradable balloon

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 8
• Est. completion date: July 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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;

• 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.

Exclusion Criteria:

• 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;

• 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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Over Weight
• Overweight

Intervention

Device:
• Tulip capsule
swallowing Tulip capsule for up to 29 days

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky Medical Center , Gastroenterology - Institute	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tulip Medical Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	36 days	Yes
Secondary	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.	36 days	No
Secondary	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	36 days	Yes