Cryoablation for Obesity Management

NCT ID: NCT03092778

Last Updated: 2018-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-13
• Study Completion Date: 2018-07-25

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.

Conditions

Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cryoablation Group

Participants with mild to moderate obesity will undergo a cryoablation procedure to the vagal nerve.

Group Type: EXPERIMENTAL

Cryoablation

Intervention Type: PROCEDURE

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.

Interventions

Cryoablation

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Endocare, Inc.

INDUSTRY

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

John Prologo

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Prologo, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31339003 (View on PubMed)

Other Identifiers

IRB00095192

Identifier Type: -

Identifier Source: org_study_id