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

Primary Purpose

Over Weight, Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Tulip capsule
Sponsored by
Tulip Medical Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Over Weight focused on measuring Over weight, Obesity

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Tel Aviv Sourasky Medical Center , Gastroenterology - Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tulip capsule

Arm Description

swallowing Tulip capsule for up to 29 days

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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

Full Information

First Posted
December 17, 2012
Last Updated
December 17, 2012
Sponsor
Tulip Medical Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01753609
Brief Title
Safety and Performance Evaluation of Tulip Device in Healthy Overweight and Obese Volunteers
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
July 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tulip Medical Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Over Weight, Obesity
Keywords
Over weight, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tulip capsule
Arm Type
Experimental
Arm Description
swallowing Tulip capsule for up to 29 days
Intervention Type
Device
Intervention Name(s)
Tulip capsule
Intervention Description
swallowing Tulip capsule for up to 29 days
Primary Outcome Measure Information:
Title
Number of subjects with device related serious adverse events
Description
Safety will be assessed descriptively by summarizing device related SAEs, gastroscopic examination, daily diary, vital sign measurements, physical examination and abdomen circumference.
Time Frame
36 days
Secondary Outcome Measure Information:
Title
Patient assessment of capsule tolerability
Description
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.
Time Frame
36 days
Title
Satisfying evacuation of the balloon from the stomach after oral intake
Description
Number of subjects showing satisfying evacuation of the balloon from the stomach after oral intake by means of a gastroscopic examination
Time Frame
36 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sigal Fishman, Dr.
Phone
972-3-6974469
Email
sigalf@tlvmc.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Tair Lapidot, Dr.
Phone
972-72-2505995
Ext
105
Email
tair@tulipmed.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sigal Fishman, Dr.
Organizational Affiliation
Tel Aviv Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel Aviv Sourasky Medical Center , Gastroenterology - Institute
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sigal Fishman, Dr.
Phone
972-3-6974469
Email
sigalf@tlvmc.gov.il
First Name & Middle Initial & Last Name & Degree
Sara Pel
Phone
972-3-6974469
Email
sarap@tlvmc.gov.il
First Name & Middle Initial & Last Name & Degree
Ron Yishai, Dr

12. IPD Sharing Statement

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

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