A Phase 1/2 interventional study of Cyberonics VNS in Crohn Disease, sponsored by SetPoint Medical Corporation. Status unknown at 4 sites in 4 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-08-03.
Sponsored by SetPoint Medical Corporation · Phase 1/2, Interventional, and Treatment
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.
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.
1,992 studies on the registry are indexed under Crohn Disease; 478 are open to participants now.
This study's planned enrollment of 15 is below the median of 67 across 1,260 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →SetPoint Medical Corporation is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cyberonics VNS
Device: Cyberonics VNS
Vagus nerve stimulation
Crohn's Disease Activity Index
Time frame: 24 months
Inflammatory Bowel Disease Questionnaire
Time frame: 24 months
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Jan 2015, a primary completion of May 2018 and a completion of Aug 2018. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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SetPoint Medical Corporation