Cryoablation for Obesity Management

Emory University20 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obesity

Interventions

CryoablationPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Emory University Hospital

Atlanta, Georgia, United States

Emory St. Joseph's Hospital

Atlanta, Georgia, United States

Emory Johns Creek Hospital

Johns Creek, Georgia, United States

Outcomes

Primary Outcomes

Number of Cryoablation Procedure Events (CPEs)

Adverse events which occur within the first 24 hours following cryoablation.

Time frame: 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.

Time frame: Duration of Study (Up to 2 Years)

Number of Significant Adverse Events (SAEs)

Significant adverse events include life-threatening adverse events and death.

Time frame: Duration of Study (Up to 2 Years)

Number of Breakthrough Events

The number of events requiring emergency or urgent physician consultation.

Time frame: Duration of Study (Up to 2 Years)

Frequency of Breakthrough Events

The frequency of events requiring emergency or urgent physician consultation.

Time frame: Duration of Study (Up to 2 Years)

Secondary Outcomes

Weight

Weight will be measured in kilograms.

Time frame: Baseline, Month 6 (Post Intervention)

Height

Height will be measured in inches.

Time frame: Baseline, Month 6 (Post Intervention)

Body Mass Index (BMI)

Body Mass Index will be measured using a BMI calculator.

Data from ClinicalTrials.gov

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