Percutaneous Image Guided Cryoablation of the Vagus Nerve for Management of Mild-Moderate Obesity
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Emory University
- Enrollment
- 20
- Locations
- 3
- Primary Endpoint
- Number of Cryoablation Procedure Events (CPEs)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Cryoablation Group
Participants with mild to moderate obesity will undergo a cryoablation procedure to the vagal nerve.
Intervention: Cryoablation (Procedure)
Outcomes
Primary Outcomes
Number of Cryoablation Procedure Events (CPEs)
Time Frame: Post Intervention (Up to 24 Hours)
Adverse events which occur within the first 24 hours following cryoablation.
Frequency of Breakthrough Events
Time Frame: Duration of Study (Up to 2 Years)
The frequency of events requiring emergency or urgent physician consultation.
Number of Breakthrough Events
Time Frame: Duration of Study (Up to 2 Years)
The number of events requiring emergency or urgent physician consultation.
Number of Adverse Events
Time Frame: 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)
Time Frame: Duration of Study (Up to 2 Years)
Significant adverse events include life-threatening adverse events and death.
Secondary Outcomes
- Recruitment Rate(Duration of Study (Up to 2 Years))
- Weight(Baseline, Month 6 (Post Intervention))
- Hip Circumference(Baseline, Month 6 (Post Intervention))
- Food Frequency Questionnaire (FFQ)(Week 1, Month 6 (Post Intervention))
- Number of Candidates who Chose not to Participate(Duration of Study (Up to 2 Years))
- Withdrawal Rate(Duration of Study (Up to 2 Years))
- Retention Rate(Duration of Study (Up to 2 Years))
- Body Mass Index (BMI)(Baseline, Month 6 (Post Intervention))
- Kaiser Physical Activity Survey (KPAS)(Week 1, Month 6 (Post Intervention))
- Enrollment Rate(Duration of Study (Up to 2 Years))
- Height(Baseline, Month 6 (Post Intervention))
- Moorehead-Ardelt Quality of Life Questionnaire(Week 1, Month 6 (Post Intervention))
- Exclusion Rate(Duration of Study (Up to 2 Years))
- Protocol Deviation Rate(Duration of Study (Up to 2 Years))
Investigators
John Prologo
Assistant Professor
Emory University