ObesityNCT03092778
Cryoablation for Obesity Management
A study testing Cryoablation in people with Obesity, run by Emory University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Cryoablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Jun 2017to 25 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory University Hospital
Atlanta, Georgia, 30322
Emory St. Joseph's Hospital
Atlanta, Georgia, 30342
Emory Johns Creek Hospital
Johns Creek, Georgia, 30097
About this study
Official title: Percutaneous Image Guided Cryoablation of the Vagus Nerve for Management of Mild-Moderate Obesity
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.
Read the 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
- Being tested
- Cryoablation
- Keywords
- Cryoablation, Radiology
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoablationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Cryoablation Group | Experimental | Participants with mild to moderate obesity will undergo a cryoablation procedure to the vagal nerve. Receives: Procedure: Cryoablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Cryoablation Procedure Events (CPEs)
Adverse events which occur within the first 24 hours following cryoablation.
Measured: 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.
Measured: Duration of Study (Up to 2 Years)
Number of Significant Adverse Events (SAEs)
Significant adverse events include life-threatening adverse events and death.
Measured: Duration of Study (Up to 2 Years)
Number of Breakthrough Events
The number of events requiring emergency or urgent physician consultation.
Measured: Duration of Study (Up to 2 Years)
Frequency of Breakthrough Events
The frequency of events requiring emergency or urgent physician consultation.
Measured: Duration of Study (Up to 2 Years)
Secondary outcomes (14)
Weight
Weight will be measured in kilograms.
Measured: Baseline, Month 6 (Post Intervention)
Height
Height will be measured in inches.
Measured: Baseline, Month 6 (Post Intervention)
Body Mass Index (BMI)
Body Mass Index will be measured using a BMI calculator.
Measured: Baseline, Month 6 (Post Intervention)
Hip Circumference
Hip Circumference will be measured in inches.
Measured: Baseline, Month 6 (Post Intervention)
Food Frequency Questionnaire (FFQ)
The FFQ is a self-reported measure where participants are asked to describe their food intake during specific time periods.
Measured: Week 1, Month 6 (Post Intervention)
Kaiser Physical Activity Survey (KPAS)
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.
Measured: Week 1, Month 6 (Post Intervention)
Moorehead-Ardelt Quality of Life Questionnaire
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".
Measured: Week 1, Month 6 (Post Intervention)
Enrollment Rate
The number of participants enrolled throughout the duration of the study.
Measured: Duration of Study (Up to 2 Years)
Recruitment Rate
The number of participants approached for enrollment throughout the duration of the study.
Measured: Duration of Study (Up to 2 Years)
Retention Rate
The number of participants that complete all study visits.
Measured: Duration of Study (Up to 2 Years)
Exclusion Rate
The number of patients excluded from participation.
Measured: Duration of Study (Up to 2 Years)
Number of Candidates who Chose not to Participate
The number of eligible patients who chose not to participate in the study.
Measured: Duration of Study (Up to 2 Years)
Withdrawal Rate
The number of details regarding patient withdrawal including deaths and lost to followup.
Measured: Duration of Study (Up to 2 Years)
Protocol Deviation Rate
The number of protocol deviations that may impact study results.
Measured: Duration of Study (Up to 2 Years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start13 Jun 2017
- Primary completion25 Jul 2018
- Study completion25 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Endocare, Inc.
- Responsible party
- Principal investigator, John Prologo, Emory University
- Investigators
- David Prologo, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03092778
- Sponsor's protocol ID
- IRB00095192
- Status last verified
- Oct 2018
- First submitted
- 24 Mar 2017
- Last updated
- 31 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31339003
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Image Guided Cryoablation of the Vagus Nerve for Management of Mild-Moderate Obesity
- ClinicalTrials.gov ID
- NCT03092778
- Acronym / sponsor ID
- IRB00095192
- Conditions
- Obesity
- Keywords
- Cryoablation, Radiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Endocare, Inc.
- Study start
- 13 Jun 2017 (actual)
- Primary completion
- 25 Jul 2018 (actual)
- Study completion
- 25 Jul 2018 (actual)
- First posted
- 28 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cryoablation Group | Experimental | Procedure: CryoablationParticipants with mild to moderate obesity will undergo a cryoablation procedure to the vagal nerve. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryoablationA 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. | Procedure or surgery | Cryoablation Group |
Primary outcome
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.
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.
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.
Number of Breakthrough Events
Time frame: Duration of Study (Up to 2 Years)
The number of events requiring emergency or urgent physician consultation.
Frequency of Breakthrough Events
Time frame: Duration of Study (Up to 2 Years)
The frequency of events requiring emergency or urgent physician consultation.
14 secondary outcomes
Weight
Time frame: Baseline, Month 6 (Post Intervention)
Height
Time frame: Baseline, Month 6 (Post Intervention)
Body Mass Index (BMI)
Time frame: Baseline, Month 6 (Post Intervention)
Hip Circumference
Time frame: Baseline, Month 6 (Post Intervention)
Food Frequency Questionnaire (FFQ)
Time frame: Week 1, Month 6 (Post Intervention)
Kaiser Physical Activity Survey (KPAS)
Time frame: Week 1, Month 6 (Post Intervention)
Moorehead-Ardelt Quality of Life Questionnaire
Time frame: Week 1, Month 6 (Post Intervention)
Enrollment Rate
Time frame: Duration of Study (Up to 2 Years)
Recruitment Rate
Time frame: Duration of Study (Up to 2 Years)
Retention Rate
Time frame: Duration of Study (Up to 2 Years)
Exclusion Rate
Time frame: Duration of Study (Up to 2 Years)
Number of Candidates who Chose not to Participate
Time frame: Duration of Study (Up to 2 Years)
Withdrawal Rate
Time frame: Duration of Study (Up to 2 Years)
Protocol Deviation Rate
Time frame: Duration of Study (Up to 2 Years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
- Derived from this study: PubMed 31339003Prologo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Prologo, MD principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoablation in people with Obesity, run by Emory University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Cryoablation Procedure Events (CPEs) (time frame: Post Intervention (Up to 24 Hours)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03092778, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2018.