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

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

Study Overview

• Status: Unknown
• Conditions: Obesity; Over Weight
• Intervention / Treatment: Device: Tulip capsule

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 Type: Interventional
• Enrollment (Anticipated): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel, 64239
    • Tel Aviv Sourasky Medical Center , Gastroenterology - Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tulip capsule; swallowing Tulip capsule for up to 29 days	Device: Tulip capsule; swallowing Tulip capsule for up to 29 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Tulip Medical Ltd.
• Investigators: Principal Investigator: Sigal Fishman, Dr., Tel Aviv Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Anticipated): March 1, 2013
• Study Completion (Anticipated): July 1, 2013

Study Registration Dates

• First Submitted: December 17, 2012
• First Submitted That Met QC Criteria: December 17, 2012
• First Posted (Estimate): December 20, 2012

Study Record Updates

• Last Update Posted (Estimate): December 20, 2012
• Last Update Submitted That Met QC Criteria: December 17, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Obesity; Over weight
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: TULIP-PRT-002-05-B-CTIL