Cryoablation for Obesity Management

NCT03092778 | Completed

• 1 other identifier: IRB00095192
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

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.

Conditions

Obesity

Keywords

Cryoablation; Radiology

Outcome Measures

Primary Outcomes (5)

• Number of Cryoablation Procedure Events (CPEs)

  Adverse events which occur within the first 24 hours following cryoablation.

  Post Intervention (Up to 24 Hours)

• Number of Adverse Events

  Clinical signs or symptoms of infection (fever), hemorrhage (pain, imaging changes), that occur outside of the time periods specified for CPEs.

  Duration of Study (Up to 2 Years)

• Number of Significant Adverse Events (SAEs)

  Significant adverse events include life-threatening adverse events and death.

  Duration of Study (Up to 2 Years)

• Number of Breakthrough Events

  The number of events requiring emergency or urgent physician consultation.

  Duration of Study (Up to 2 Years)

• Frequency of Breakthrough Events

  The frequency of events requiring emergency or urgent physician consultation.

  Duration of Study (Up to 2 Years)

Secondary Outcomes (14)

• Weight

  Baseline, Month 6 (Post Intervention)

• Height

  Baseline, Month 6 (Post Intervention)

• Body Mass Index (BMI)

  Baseline, Month 6 (Post Intervention)

• Hip Circumference

  Baseline, Month 6 (Post Intervention)

• Food Frequency Questionnaire (FFQ)

  Week 1, Month 6 (Post Intervention)

Study Arms (1)

Cryoablation Group

EXPERIMENTAL

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

Procedure: Cryoablation

Interventions

Cryoablation 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.

Cryoablation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• Endocare, Inc.: collaborator

Study Sites (3)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Emory St. Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

Emory Johns Creek Hospital

Johns Creek, Georgia, 30097, United States

Location

Related Publications (1)

• 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.

  PMID: 31339003 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative

Study Officials

• David Prologo, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 24, 2017
• First Posted: March 28, 2017
• Study Start: June 13, 2017
• Primary Completion: July 25, 2018
• Study Completion: July 25, 2018
• Last Updated: October 31, 2018

Record last verified: 2018-10

Locations

US (3)