NCT02951650

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.

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
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2015

Typical duration for phase_1

Geographic Reach
4 countries

4 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

January 1, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 3, 2017

Status Verified

August 1, 2017

Enrollment Period

3.3 years

First QC Date

October 29, 2016

Last Update Submit

August 2, 2017

Conditions

Crohn Disease

Keywords

vagus nerve stimulation

Outcome Measures

Primary Outcomes (1)

  • Crohn's Disease Activity Index

    24 months

Secondary Outcomes (1)

  • Inflammatory Bowel Disease Questionnaire

    24 months

Study Arms (1)

Cyberonics VNS

EXPERIMENTAL

Cyberonics VNS

Device: Cyberonics VNS

Interventions

Cyberonics VNSDEVICE

Vagus nerve stimulation

Cyberonics VNS

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Inability to provide informed consent Significant psychiatric illness or substance abuse
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Dubrava Hospital

Zagreb, Croatia

Location

Humanitas Research Hospital

Milan, Italy

Location

Academic Medical Center

Amsterdam, Netherlands

Location

Karolinska Institute

Stockholm, Sweden

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Geert D'Haens, M.D., Ph.D.

    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2016

First Posted

November 1, 2016

Study Start

January 1, 2015

Primary Completion

May 1, 2018

Study Completion

August 1, 2018

Last Updated

August 3, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

CR(1)NL(1)SE(1)IT(1)