Clinical trial NCT03092778: Cryoablation for Obesity Management
Official title: Percutaneous Image Guided Cryoablation of the Vagus Nerve for Management of Mild-Moderate Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Cryoablation
Radiology
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Endocare, Inc.
First posted: 2017-03-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Cryoablation Procedure Events (CPEs)
timeFrame: Post Intervention (Up to 24 Hours)
measure: Number of Adverse Events
timeFrame: Duration of Study (Up to 2 Years)
measure: Number of Significant Adverse Events (SAEs)
timeFrame: Duration of Study (Up to 2 Years)
measure: Number of Breakthrough Events
timeFrame: Duration of Study (Up to 2 Years)
measure: Frequency of Breakthrough Events
timeFrame: Duration of Study (Up to 2 Years)
Secondary outcomes:
measure: Weight
timeFrame: Baseline, Month 6 (Post Intervention)
measure: Height
timeFrame: Baseline, Month 6 (Post Intervention)
measure: Body Mass Index (BMI)
timeFrame: Baseline, Month 6 (Post Intervention)
measure: Hip Circumference
timeFrame: Baseline, Month 6 (Post Intervention)
measure: Food Frequency Questionnaire (FFQ)
timeFrame: Week 1, Month 6 (Post Intervention)
measure: Kaiser Physical Activity Survey (KPAS)
timeFrame: Week 1, Month 6 (Post Intervention)
measure: Moorehead-Ardelt Quality of Life Questionnaire
timeFrame: Week 1, Month 6 (Post Intervention)
measure: Enrollment Rate
timeFrame: Duration of Study (Up to 2 Years)
measure: Recruitment Rate
timeFrame: Duration of Study (Up to 2 Years)
measure: Retention Rate
timeFrame: Duration of Study (Up to 2 Years)
measure: Exclusion Rate
timeFrame: Duration of Study (Up to 2 Years)
measure: Number of Candidates who Chose not to Participate
timeFrame: Duration of Study (Up to 2 Years)
measure: Withdrawal Rate
timeFrame: Duration of Study (Up to 2 Years)
measure: Protocol Deviation Rate
timeFrame: Duration of Study (Up to 2 Years)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory St. Joseph's Hospital
state: Georgia
city: Johns Creek
country: United States
facility: Emory Johns Creek Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: David Prologo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Prologo JD, Lin E, Horesh Bergquist S, Knight J, Matta H, Brummer M, Singh A, Patel Y, Corn D. Percutaneous CT-Guided Cryovagotomy in Patients with Class I or Class II Obesity: A Pilot Trial. Obesity (Silver Spring). 2019 Aug;27(8):1255-1265. doi: 10.1002/oby.22523.