Percutaneous CT-guided Cryoablation of the Splanchnic Nerves

NCT04569721 | Withdrawn DMC FDA Device

• 1 other identifier: STUDY00000619
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of freezing (cryoablation) of the splanchnic nerve for management of diabetes. The splanchnic nerves carry signals from the brain to help regulate the way organs function. Quieting these signals, by freezing the splanchnic nerves, may help the body regulate blood sugar. The study procedure will take about 30 minutes and the researchers hope that it will help people to control their blood sugars, lose weight, and possibly improve blood pressure.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• Mortality

  The number of participant deaths will be used to assess the safety of the study procedure.

  Month 12

• Number of Procedure Related Complications

  Safety will be assessed by examining procedure related complications, such as bleeding, infection, hypotension, pain, cardiac abnormalities, gastrointestinal abnormalities, or endocrine abnormalities.

  Month 12

Secondary Outcomes (17)

• Change in Hemoglobin A1c (HbA1c)

  Baseline, Months 1, 3, 6, and 12

• Change in Fasting Glucose

  Baseline, Day 7, Months 1, 3, 6, and 12

• Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

  Baseline, Months 1, 3, 6, and 12

• Change in Body Weight

  Baseline, Months 1, 3, 6, and 12

• Change in Waist Circumference

  Baseline, Months 1, 3, 6, and 12

Study Arms (1)

CT guided splanchnic cryoablation

EXPERIMENTAL

Obese patients with type 2 diabetes receiving CT guided splanchnic cryoablation.

Device: CT Guided Splanchnic Cryoablation

Interventions

CT Guided Splanchnic Cryoablation DEVICE

The patient will be sedated and continuously monitored by the anesthesia team, who will be present for the entire procedure. The puncture site will be anesthetized with 1% Lidocaine infiltration. Following tract anesthesia, and utilizing fluoroscopic CT guidance, four cryoablation probes (Ice Rods®) will be advanced, 2 on each side. In addition, a temperature monitoring probe (Boston Scientific, Multipoint 1.5 Thermal Sensor®) will be advanced on each side. The cryoablation process will include a 10-minute freeze, followed by a 3-minute passive thaw, and a brief active thaw to facilitate probe removal. A final scan will be obtained following removal of the probes. After the procedure, a sterile dressing will be applied, and subjects will be monitored for at least 12 hours in an observation bed in the hospital post-procedure.

CT guided splanchnic cryoablation

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Type 2 diabetes mellitus (T2DM) for \<10 years
• HbA1c between ≥7.5% and ≤10.5%
• Willing to comply with study requirements
• Subjects have failed lifestyle interventions as a first line treatment
• Body mass index (BMI) between 30 and 37

You may not qualify if:

• Diagnosis of type 1 diabetes or history of diabetic ketoacidosis
• Thyroid disease unless on stable medications for \>3 months
• Systemic steroid use within 30 days
• Use of prescription or over the counter weight loss medications within 6 months prior to randomization
• Any condition or major illness that places the subject at undue risk by participating in the study
• Psychiatric condition rendering the subject unable to understand the possible consequences of the study
• Inability to provide informed consent
• Positive pregnancy test at time of cryoablation procedure
• Female subjects who have been pregnant within 6 months or breast-feeding at time of enrollment into the study, or women who plan to become pregnant within the next 12 months
• Diagnosis of anemia, red blood cell (RBC) transfusion in the preceding 3 months or expectation to receive transfusion within the next 12 months, or hemoglobinopathies that would affect HbA1c reliability
• Active or recent infection
• Immunosuppression
• History of coagulopathy or high risk for development of deep vein thrombosis (including congestive heart failure, those who are non-ambulatory, active leukemia/lymphoma, prior thrombotic events, family history of thrombosis)
• History of autonomic dysfunction, including amyloidosis, Parkinson's disease, autoimmune disease, spinal cord injury
• History of heart failure

Sponsors & Collaborators

• Emory University: lead
• Georgia Research Alliance: collaborator

Study Sites (1)

Emory Johns Creek Hospital

Johns Creek, Georgia, 30097, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• John D Prologo, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: September 30, 2020
• Study Start: February 19, 2021
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)