NCT01753609

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 20, 2012

Completed
12 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

December 20, 2012

Status Verified

December 1, 2012

Enrollment Period

2 months

First QC Date

December 17, 2012

Last Update Submit

December 17, 2012

Conditions

Over WeightObesity

Keywords

Over weightObesity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Patient assessment of capsule tolerability

    36 days

  • Satisfying evacuation of the balloon from the stomach after oral intake

    36 days

Study Arms (1)

Tulip capsule

EXPERIMENTAL

swallowing Tulip capsule for up to 29 days

Device: Tulip capsule

Interventions

Tulip capsuleDEVICE

swallowing Tulip capsule for up to 29 days

Tulip capsule

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≤ Age \<65 years
  • \< 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.

You may not qualify if:

  • 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;
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Sourasky Medical Center , Gastroenterology - Institute

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Obesity

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ProstatectomyUrologic Surgical Procedures, MaleUrologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Sigal Fishman, Dr.

    Tel Aviv Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sigal Fishman, Dr.

CONTACT

972-3-6974469sigalf@tlvmc.gov.il

Tair Lapidot, Dr.

CONTACT

972-72-2505995tair@tulipmed.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2012

First Posted

December 20, 2012

Study Start

January 1, 2013

Primary Completion

March 1, 2013

Study Completion

July 1, 2013

Last Updated

December 20, 2012

Record last verified: 2012-12

Locations

IL(1)