A Study of Vagus Nerve Blocking for Obesity Control

Overview

About this study

The purpose of this study is to measure the safety and effectiveness of the Maestro System to reduce body weight by blocking signals from the vagus nerve in people who are considered to be obese.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Informed consent
  • Body mass index (BMI) ≥ 40 kg/m2 to 45 kg/m2 
  • BMI ≥ 35 kg/m2 to 39.9 kg/m2 with one or more severe obesity related co-morbid conditions
  • Female or male
  • Age 18-65 years inclusive
  • Type 2 diabetes mellitus that is well-controlled
    • At selected centers
    • Limited to approximately 26 subjects
  • Failed to respond to a supervised diet/exercise program engaged in for at least 6 months
  • Able to complete all study visits and procedures

Exclusion Criteria

  • Concurrent chronic pancreatic disease
  • History of Crohn's disease and/or ulcerative colitis
  • History of bariatric surgery, fundoplication, gastric resection or major upper-abdominal surgery
  • History of pulmonary embolism or blood coagulation disorders
  • Clinically significant hiatal hernia known from medical record or determined by upper endoscopy prior to implant
  • Current portal hypertension and/or esophageal varices
  • Intra-operative exclusion for hiatal hernia requiring surgical repair or extensive dissection at esophagogastric junction at the time of surgery
  • Treatment with weight-loss prescription drug therapy within the prior three months, and the use of prescription drug therapy or over-the-counter weight loss preparations for the duration of the trial
  • Smoking cessation within the prior six months
  • Known genetic cause of obesity
  • Overall sustained reduction of more than 10% of body weight in the previous 12 months
  • Pre-operative diet with intent to lose weight prior to surgery

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Florencia Que, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20315807

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