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

Tulip Medical

Status

Unknown

Conditions

Obesity

Over Weight

Treatments

Device: Tulip capsule

Study type

Interventional

Funder types

Industry

Identifiers

NCT01753609

TULIP-PRT-002-05-B-CTIL

Details and patient eligibility

About

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

Full 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.

Enrollment

8 estimated patients

Sex

All

Ages

21 to 65 years old

Volunteers

Accepts 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.