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Cryoablation for Obesity Management

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ClinicalTrials.gov Identifier: NCT03092778
Recruitment Status : Completed
First Posted : March 28, 2017
Last Update Posted : October 31, 2018
Sponsor:
Collaborator:
Endocare, Inc.
Information provided by (Responsible Party):
John Prologo, Emory University

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.

Condition or disease Intervention/treatment Phase
Obesity Procedure: Cryoablation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Percutaneous Image Guided Cryoablation of the Vagus Nerve for Management of Mild-Moderate Obesity
Actual Study Start Date : June 13, 2017
Actual Primary Completion Date : July 25, 2018
Actual Study Completion Date : July 25, 2018

Arm Intervention/treatment
Experimental: Cryoablation Group
Participants with mild to moderate obesity will undergo a cryoablation procedure to the vagal nerve.
Procedure: 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.





Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Number of Breakthrough Events [ Time Frame: Duration of Study (Up to 2 Years) ]
    The number of events requiring emergency or urgent physician consultation.

  5. Frequency of Breakthrough Events [ Time Frame: Duration of Study (Up to 2 Years) ]
    The frequency of events requiring emergency or urgent physician consultation.


Secondary Outcome Measures :
  1. Weight [ Time Frame: Baseline, Month 6 (Post Intervention) ]
    Weight will be measured in kilograms.

  2. Height [ Time Frame: Baseline, Month 6 (Post Intervention) ]
    Height will be measured in inches.

  3. Body Mass Index (BMI) [ Time Frame: Baseline, Month 6 (Post Intervention) ]
    Body Mass Index will be measured using a BMI calculator.

  4. Hip Circumference [ Time Frame: Baseline, Month 6 (Post Intervention) ]
    Hip Circumference will be measured in inches.

  5. Food Frequency Questionnaire (FFQ) [ Time Frame: Week 1, Month 6 (Post Intervention) ]
    The FFQ is a self-reported measure where participants are asked to describe their food intake during specific time periods.

  6. Kaiser Physical Activity Survey (KPAS) [ Time Frame: Week 1, Month 6 (Post Intervention) ]
    The KPAS is a self-report measure regarding physical activity and living habits. There are four different sections; household and family care activities, occupational activities, active living habits, and participation in sports and exercise. Sections are scored independently on a consecutive scale.

  7. Moorehead-Ardelt Quality of Life Questionnaire [ Time Frame: Week 1, Month 6 (Post Intervention) ]
    The Moorehead-Ardelt Quality of Life Questionnaire is a self-reported measure regarding self-esteem and physical activity levels. Total scores range from -3 to 3, where -3 indicates "very poor" and 3 indicates "very good".

  8. Enrollment Rate [ Time Frame: Duration of Study (Up to 2 Years) ]
    The number of participants enrolled throughout the duration of the study.

  9. Recruitment Rate [ Time Frame: Duration of Study (Up to 2 Years) ]
    The number of participants approached for enrollment throughout the duration of the study.

  10. Retention Rate [ Time Frame: Duration of Study (Up to 2 Years) ]
    The number of participants that complete all study visits.

  11. Exclusion Rate [ Time Frame: Duration of Study (Up to 2 Years) ]
    The number of patients excluded from participation.

  12. Number of Candidates who Chose not to Participate [ Time Frame: Duration of Study (Up to 2 Years) ]
    The number of eligible patients who chose not to participate in the study.

  13. Withdrawal Rate [ Time Frame: Duration of Study (Up to 2 Years) ]
    The number of details regarding patient withdrawal including deaths and lost to followup.

  14. Protocol Deviation Rate [ Time Frame: Duration of Study (Up to 2 Years) ]
    The number of protocol deviations that may impact study results.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03092778


Locations
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United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Emory St. Joseph's Hospital
Atlanta, Georgia, United States, 30342
Emory Johns Creek Hospital
Johns Creek, Georgia, United States, 30097
Sponsors and Collaborators
Emory University
Endocare, Inc.
Investigators
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Principal Investigator: David Prologo, MD Emory University

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Responsible Party: John Prologo, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT03092778     History of Changes
Other Study ID Numbers: IRB00095192
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by John Prologo, Emory University:
Cryoablation
Radiology

Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms