Cryoablation for Obesity Management

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.

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