- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03092778
Cryoablation for Obesity Management
Percutaneous Image Guided Cryoablation of the Vagus Nerve for Management of Mild-Moderate Obesity
Study Overview
Detailed Description
The purpose of this single arm study is to assess the efficacy of cryoablation therapy for the treatment of mild to moderate obesity and test the safety (good and bad effects) of this procedure. The vagus nerve transmits hunger signals from the stomach to the brain, and in response transmits stomach expansion signals from the brain to the stomach.Investigators believe that by interrupting this communication, participants could experience less hunger and in turn lose weight.
The rationale for using cryoablation to treat obesity is based on this investigator's experience safely targeting peripheral nerves via CT guidance and treated with thermal ablation in daily clinical practice. the primary objective of this research is to evaluate the feasibility and safety (over time) of percutaneous image guided cryoablation of the posterior vagus nerve in obese patients. The secondary objective consist of temporal evaluation of weight loss and appetite before and after the procedure. This will be analyzed through documentation of weight, and through the implementation of validated outcome instruments.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Georgia
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Atlanta, Georgia, United States, 30322
- Emory University Hospital
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Atlanta, Georgia, United States, 30342
- Emory St. Joseph's Hospital
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Johns Creek, Georgia, United States, 30097
- Emory Johns Creek Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Body Mass Index (BMI) 30-35
- Weight loss refractory to diet changes or exercise
- Absence of coagulopathy
- Ability and willingness of patient to provide written informed consent
Exclusion Criteria:
- Active infection
- Underlying congenital anatomic or other spinal anomalies that result in non-conventional anatomy at the gastro-esophageal junction
- Pregnant or planning to become pregnant
- Immunosuppression
- History or laboratory results indicative of any significant cardiac, endocrine, hematologic, hepatic, immunologic, infectious, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neoplastic, or other disorder that in the opinion of the Principal Investigator would preclude the safe performance of cryoablation
- Uncorrectable coagulopathies
- Concurrent participation in another investigational trial involving systemic administration of agents or within the previous 30 days
- Have undergone a previous bariatric surgical intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cryoablation Group
Participants with mild to moderate obesity will undergo a cryoablation procedure to the vagal nerve.
|
A computed tomography (CT) scan will be completed to map out where to insert the cryoablation needle. Numbing medicine will be used to numb the skin and deeper tissues before inserting the needle. The cryoablation needle will be inserted and directed toward the target area of the vagal nerve. A CT scan will be done during the procedure to help guide the needle which will be held in position by the study doctor(s) once it reaches the target area. With the needle in place, the study doctor(s) will freeze the zone over 3 minutes, a 2 minutes thaw will follow, then 2 more cycles of 3 minutes freeze and 2 minute thaw will complete the procedure. This portion of the procedure can last from 25 to 35 minutes. Once the targeted area has been properly treated, the cryoablation needle will be withdrawn. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Cryoablation Procedure Events (CPEs)
Time Frame: Post Intervention (Up to 24 Hours)
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Adverse events which occur within the first 24 hours following cryoablation.
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Post Intervention (Up to 24 Hours)
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Number of Adverse Events
Time Frame: Duration of Study (Up to 2 Years)
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Clinical signs or symptoms of infection (fever), hemorrhage (pain, imaging changes), that occur outside of the time periods specified for CPEs.
|
Duration of Study (Up to 2 Years)
|
Number of Significant Adverse Events (SAEs)
Time Frame: Duration of Study (Up to 2 Years)
|
Significant adverse events include life-threatening adverse events and death.
|
Duration of Study (Up to 2 Years)
|
Number of Breakthrough Events
Time Frame: Duration of Study (Up to 2 Years)
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The number of events requiring emergency or urgent physician consultation.
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Duration of Study (Up to 2 Years)
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Frequency of Breakthrough Events
Time Frame: Duration of Study (Up to 2 Years)
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The frequency of events requiring emergency or urgent physician consultation.
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Duration of Study (Up to 2 Years)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight
Time Frame: Baseline, Month 6 (Post Intervention)
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Weight will be measured in kilograms.
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Baseline, Month 6 (Post Intervention)
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Height
Time Frame: Baseline, Month 6 (Post Intervention)
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Height will be measured in inches.
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Baseline, Month 6 (Post Intervention)
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Body Mass Index (BMI)
Time Frame: Baseline, Month 6 (Post Intervention)
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Body Mass Index will be measured using a BMI calculator.
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Baseline, Month 6 (Post Intervention)
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Hip Circumference
Time Frame: Baseline, Month 6 (Post Intervention)
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Hip Circumference will be measured in inches.
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Baseline, Month 6 (Post Intervention)
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Food Frequency Questionnaire (FFQ)
Time Frame: Week 1, Month 6 (Post Intervention)
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The FFQ is a self-reported measure where participants are asked to describe their food intake during specific time periods.
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Week 1, Month 6 (Post Intervention)
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Kaiser Physical Activity Survey (KPAS)
Time Frame: Week 1, Month 6 (Post Intervention)
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The KPAS is a self-report measure regarding physical activity and living habits.
There are four different sections; household and family care activities, occupational activities, active living habits, and participation in sports and exercise.
Sections are scored independently on a consecutive scale.
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Week 1, Month 6 (Post Intervention)
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Moorehead-Ardelt Quality of Life Questionnaire
Time Frame: Week 1, Month 6 (Post Intervention)
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The Moorehead-Ardelt Quality of Life Questionnaire is a self-reported measure regarding self-esteem and physical activity levels.
Total scores range from -3 to 3, where -3 indicates "very poor" and 3 indicates "very good".
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Week 1, Month 6 (Post Intervention)
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Enrollment Rate
Time Frame: Duration of Study (Up to 2 Years)
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The number of participants enrolled throughout the duration of the study.
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Duration of Study (Up to 2 Years)
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Recruitment Rate
Time Frame: Duration of Study (Up to 2 Years)
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The number of participants approached for enrollment throughout the duration of the study.
|
Duration of Study (Up to 2 Years)
|
Retention Rate
Time Frame: Duration of Study (Up to 2 Years)
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The number of participants that complete all study visits.
|
Duration of Study (Up to 2 Years)
|
Exclusion Rate
Time Frame: Duration of Study (Up to 2 Years)
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The number of patients excluded from participation.
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Duration of Study (Up to 2 Years)
|
Number of Candidates who Chose not to Participate
Time Frame: Duration of Study (Up to 2 Years)
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The number of eligible patients who chose not to participate in the study.
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Duration of Study (Up to 2 Years)
|
Withdrawal Rate
Time Frame: Duration of Study (Up to 2 Years)
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The number of details regarding patient withdrawal including deaths and lost to followup.
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Duration of Study (Up to 2 Years)
|
Protocol Deviation Rate
Time Frame: Duration of Study (Up to 2 Years)
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The number of protocol deviations that may impact study results.
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Duration of Study (Up to 2 Years)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David Prologo, MD, Emory University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00095192
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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