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Trial record 3 of 5 for:    SetPoint Medical Corporation

Long Term Observational Study of a Vagal Nerve Stimulation Device in Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02951650
Recruitment Status : Active, not recruiting
First Posted : November 1, 2016
Last Update Posted : August 3, 2017
Sponsor:
Information provided by (Responsible Party):
SetPoint Medical Corporation

Brief Summary:
This will be an open label multicenter study of the safety and efficacy of an active implantable VNS device in patients with Crohn's Disease.

Condition or disease Intervention/treatment Phase
Crohn Disease Device: Cyberonics VNS Phase 1 Phase 2

Detailed Description:

Patients who complete study SPM-007 will be enrolled in this study at the time of the last visit of the preceding study. The assessments at the last visit of the preceding study will also be used as baseline measures for the current study. If the patient has previously discontinued SPM-007 and greater than 30 days have elapsed since the final visit in SPM-007, baseline measures for the current study will be repeated, and an interim medical history will be taken to assess whether any new medical conditions were diagnosed in the time between studies.

The study will continue until the last patient entered has completed 24 months in this study.

Follow-up visits will occur at 3, 6, 12, 18 and 24 months. A final follow-up visit will occur for all remaining patients at study closure when the final enrolled subject has completed 24 months on study.

An Interim Visit must be performed a maximum of 1 month after any change in device settings. Interim visits may also be performed at any time at the principal investigator's discretion; either between scheduled visits, or after the patient has completed the Month 24 Visit, if the study is still ongoing.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long Term Observational Study of the Safety and Efficacy of an Active Implantable Vagal Nerve Stimulation Device in Patients With Crohn's Disease
Study Start Date : January 2015
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Cyberonics VNS
Cyberonics VNS
Device: Cyberonics VNS
Vagus nerve stimulation



Primary Outcome Measures :
  1. Crohn's Disease Activity Index [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Inflammatory Bowel Disease Questionnaire [ Time Frame: 24 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients must have enrolled in study SPM-007; including patients who either completed that study or withdrew before completion of that study.

Exclusion Criteria:

Inability to provide informed consent Significant psychiatric illness or substance abuse

All patients will be excluded who have developed any of these exclusionary conditions during the SMP-007 study, or in the interim between SPM-007 and the Day 0 of SPM-010:

  • History of unilateral or bilateral vagotomy
  • History of recurrent vaso-vagal syncope episodes
  • Known obstructive sleep apnea
  • Known history of cardiac rhythm disturbances, atrio-ventricular block of greater than first degree, or cardiac conduction pathway abnormalities other than isolated right bundle branch block or isolated left anterior fascicle block.
  • Significant pharyngeal dysfunction or swallowing difficulties
  • Clinically significant vocal cord damage or hoarseness
  • Other implanted electrically active medical devices (e.g., cardiac pacemakers, automatic implantable cardioverter-defibrillators)
  • Asthma or chronic obstructive pulmonary disease not controlled by medications, or any other disease causing clinically significant dyspnea
  • A greater than or equal to 40 pack-year smoking history
  • Active peptic ulcer disease
  • Patients with a limited life expectancy due to terminal illness

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): NCT02951650


Locations
Croatia
Dubrava Hospital
Zagreb, Croatia
Italy
Humanitas Research Hospital
Milan, Italy
Netherlands
Academic Medical Center
Amsterdam, Netherlands
Sweden
Karolinska Institute
Stockholm, Sweden
Sponsors and Collaborators
SetPoint Medical Corporation
Investigators
Principal Investigator: Geert D'Haens, M.D., Ph.D. Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Responsible Party: SetPoint Medical Corporation
ClinicalTrials.gov Identifier: NCT02951650     History of Changes
Other Study ID Numbers: SPM-010
First Posted: November 1, 2016    Key Record Dates
Last Update Posted: August 3, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by SetPoint Medical Corporation:
vagus nerve stimulation

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases