Cryoablation for Obesity Management

Study Overview
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Brief Summary
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The purpose of this 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.

Detailed Description
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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.

Official Title
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Percutaneous Image Guided Cryoablation of the Vagus Nerve for Management of Mild-Moderate Obesity

Conditions
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Obesity

Intervention / Treatment
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* Procedure: Cryoablation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cryoablation Group<br>Participants with mild to moderate obesity will undergo a cryoablation procedure to the vagal nerve. | Procedure: Cryoablation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Cryoablation Procedure Events (CPEs) | Adverse events which occur within the first 24 hours following cryoablation. | Post Intervention (Up to 24 Hours) | 
| Number of Adverse Events | 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) | Significant adverse events include life-threatening adverse events and death. | Duration of Study (Up to 2 Years) | 
| Number of Breakthrough Events | The number of events requiring emergency or urgent physician consultation. | Duration of Study (Up to 2 Years) | 
| Frequency of Breakthrough Events | The frequency of events requiring emergency or urgent physician consultation. | Duration of Study (Up to 2 Years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Weight will be measured in kilograms. | Baseline, Month 6 (Post Intervention) | 
| Height | Height will be measured in inches. | Baseline, Month 6 (Post Intervention) | 
| Body Mass Index (BMI) | Body Mass Index will be measured using a BMI calculator. | Baseline, Month 6 (Post Intervention) | 
| Hip Circumference | Hip Circumference will be measured in inches. | Baseline, Month 6 (Post Intervention) | 
| Food Frequency Questionnaire (FFQ) | The FFQ is a self-reported measure where participants are asked to describe their food intake during specific time periods. | Week 1, Month 6 (Post Intervention) | 
| Kaiser Physical Activity Survey (KPAS) | 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. | Week 1, Month 6 (Post Intervention) | 
| Moorehead-Ardelt Quality of Life Questionnaire | 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. | Week 1, Month 6 (Post Intervention) | 
| Enrollment Rate | The number of participants enrolled throughout the duration of the study. | Duration of Study (Up to 2 Years) | 
| Recruitment Rate | The number of participants approached for enrollment throughout the duration of the study. | Duration of Study (Up to 2 Years) | 
| Retention Rate | The number of participants that complete all study visits. | Duration of Study (Up to 2 Years) | 
| Exclusion Rate | The number of patients excluded from participation. | Duration of Study (Up to 2 Years) | 
| Number of Candidates who Chose not to Participate | The number of eligible patients who chose not to participate in the study. | Duration of Study (Up to 2 Years) | 
| Withdrawal Rate | The number of details regarding patient withdrawal including deaths and lost to followup. | Duration of Study (Up to 2 Years) | 
| Protocol Deviation Rate | The number of protocol deviations that may impact study results. | Duration of Study (Up to 2 Years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cryoablation, Radiology