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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2012 by Tulip Medical Ltd.
Sponsor:
Information provided by (Responsible Party):
Tulip Medical Ltd.
ClinicalTrials.gov Identifier:
NCT01753609
First received: December 17, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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


Condition Intervention
Over Weight
Obesity
Device: Tulip capsule

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

Resource links provided by NLM:


Further study details as provided by Tulip Medical Ltd.:

Primary Outcome Measures:
  • Number of subjects with device related serious adverse events [ Time Frame: 36 days ] [ Designated as safety issue: Yes ]
    Safety will be assessed descriptively by summarizing device related SAEs, gastroscopic examination, daily diary, vital sign measurements, physical examination and abdomen circumference.


Secondary Outcome Measures:
  • Patient assessment of capsule tolerability [ Time Frame: 36 days ] [ Designated as safety issue: No ]
    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.

  • Satisfying evacuation of the balloon from the stomach after oral intake [ Time Frame: 36 days ] [ Designated as safety issue: Yes ]
    Number of subjects showing satisfying evacuation of the balloon from the stomach after oral intake by means of a gastroscopic examination


Estimated Enrollment: 8
Study Start Date: January 2013
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tulip capsule
swallowing Tulip capsule for up to 29 days
Device: Tulip capsule
swallowing Tulip capsule for up to 29 days

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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01753609

Contacts
Contact: Sigal Fishman, Dr. 972-3-6974469 sigalf@tlvmc.gov.il
Contact: Tair Lapidot, Dr. 972-72-2505995 ext 105 tair@tulipmed.com

Locations
Israel
Tel Aviv Sourasky Medical Center , Gastroenterology - Institute Not yet recruiting
Tel Aviv, Israel, 64239
Contact: Sigal Fishman, Dr.    972-3-6974469    sigalf@tlvmc.gov.il   
Contact: Sara Pel    972-3-6974469    sarap@tlvmc.gov.il   
Sub-Investigator: Ron Yishai, Dr         
Sponsors and Collaborators
Tulip Medical Ltd.
Investigators
Principal Investigator: Sigal Fishman, Dr. Tel Aviv Medical Center
  More Information

No publications provided

Responsible Party: Tulip Medical Ltd.
ClinicalTrials.gov Identifier: NCT01753609     History of Changes
Other Study ID Numbers: TULIP-PRT-002-05-B-CTIL
Study First Received: December 17, 2012
Last Updated: December 17, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Tulip Medical Ltd.:
Over weight
Obesity

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 31, 2014