NCT00555958

Brief Summary

To determine the safety, efficacy and treatment algorithm(s) of the Maestro System in causing weight loss in obese subjects - This study will provide feasibility data regarding the potential of intra-abdominal vagus nerve down-regulation/block in the treatment of obesity.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Nov 2005

Longer than P75 for not_applicable obesity

Geographic Reach
4 countries

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 9, 2007

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

February 2, 2012

Status Verified

February 1, 2012

Enrollment Period

5.8 years

First QC Date

November 8, 2007

Last Update Submit

February 1, 2012

Conditions

Obesity

Keywords

ObesityBariatric surgeryExcess weight lossVagus nerveVagal blockingVBLOC(TM) therapy

Outcome Measures

Primary Outcomes (2)

  • Excess weight loss (EWL)

    4 and 12 weeks, and 6, 12, 24, 36, 48 and 60 months

  • Serious Adverse Events (SAE) and Unanticipated Adverse Device Effects (UADE)

    4 and 12 weeks, and 6, 12, 24, 36, 48 and 60 months

Study Arms (1)

A

EXPERIMENTAL

All study subjects will be implanted with the Maestro System, and all will receive VBLOC therapy.

Device: Active, implantable, intra-abdominal vagal blocking medical device

Interventions

Active, implantable, intra-abdominal vagal blocking medical deviceDEVICE

Intermittent, programmable, intra-abdominal vagal blocking

A

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index (BMI) 35-50 +/- 10% inclusive
  • Failure to respond to diet/exercise program

You may not qualify if:

  • History of gastric resection or major upper-abdominal surgery (e.g. cholycystectomy, hysterectomy acceptable)
  • Current type 1 diabetes mellitus (DM) or poorly controlled type 2 DM
  • Reductions of more than 10% of body weight in the previous 12 months
  • Current medical condition that would make subject unfit for surgery under general anesthesia or that would be exacerbated by intentional weight loss

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

Location

Institute of Weight Control

Sydney, 2153, Australia

Location

Instituto Nacional de la Nutrición Salvador Zubiran (INNSZ)

Mexico City, 14000, Mexico

Location

National Center for Advanced Laparoscopic Surgery, St. Olavs University Hospital

Trondheim, 7489, Norway

Location

University Hospital Basel, Department of Internal Medicine

Basel, 4031, Switzerland

Location

Related Publications (1)

  • Shikora S, Toouli J, Herrera MF, Kulseng B, Zulewski H, Brancatisano R, Kow L, Pantoja JP, Johnsen G, Brancatisano A, Tweden KS, Knudson MB, Billington CJ. Vagal blocking improves glycemic control and elevated blood pressure in obese subjects with type 2 diabetes mellitus. J Obes. 2013;2013:245683. doi: 10.1155/2013/245683. Epub 2013 Jul 30.

    PMID: 23984050DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2007

First Posted

November 9, 2007

Study Start

November 1, 2005

Primary Completion

September 1, 2011

Study Completion

September 1, 2014

Last Updated

February 2, 2012

Record last verified: 2012-02

Locations

CH(1)AU(2)NO(1)ME(1)