Cryoablation for Obesity Management

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Procedure: Cryoablation

• Registration Number: NCT03092778
• Lead Sponsor: Emory University

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-03-24
• Study First Submitted QC: 2017-03-24
• Study First Posted: 2017-03-28
• Study Start: 2017-06-13
• Primary Completion: 2018-07-25
• Study Completion: 2018-07-25
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-30
• Last Update Posted: 2018-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cryoablation Group	Cryoablation	Participants with mild to moderate obesity will undergo a cryoablation procedure to the vagal nerve.

Primary Outcome Measures

Name	Time	Method
Number of Cryoablation Procedure Events (CPEs)	Post Intervention (Up to 24 Hours)	Adverse events which occur within the first 24 hours following cryoablation.
Frequency of Breakthrough Events	Duration of Study (Up to 2 Years)	The frequency of events requiring emergency or urgent physician consultation.
Number of Breakthrough Events	Duration of Study (Up to 2 Years)	The number of events requiring emergency or urgent physician consultation.
Number of Adverse Events	Duration of Study (Up to 2 Years)	Clinical signs or symptoms of infection (fever), hemorrhage (pain, imaging changes), that occur outside of the time periods specified for CPEs.
Number of Significant Adverse Events (SAEs)	Duration of Study (Up to 2 Years)	Significant adverse events include life-threatening adverse events and death.

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Emory St. Joseph's Hospital; 🇺🇸 Atlanta, Georgia, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Emory Johns Creek Hospital; 🇺🇸 Johns Creek, Georgia, United States