Chronic Cerebral Spinal Venous InsufficiencyNCT01593358
Venous Obstruction in Neurodegenerative Disorders Research Registry
An observational study of Chronic Cerebral Spinal Venous Insufficiency, run by Synergy Health Concepts, Inc. at 1 site in United States.
Trial summary
To establish if there are venous obstructions in patients with neurodegenerative disorders Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Cerebral Spinal Venous Insufficiency
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Human subjects will be approached for participation in this registry that are receiving or seeking medical care at Synergy Health Concepts, Inc.No individuals shall be excluded from participation in the Research Registry based on race, ethnicity, or gender.
Who may be able to join
- Ability to comprehend the nature of the study, including the risks and benefits and execute an informed consent
- Males or Females between the ages of 18 and 90 years of age
- Voluntary agreement to participate in the Venous Obstructions in Neurodegenerative Diseases Research Registry
Who cannot join
- Any implantable/metallic objects that prevent subject from having a magnetic resonance imaging ( MRI/MRV) study
- History of uncontrolled hypertension
- Previous venous angioplasty treatment for Chronic cerebral spinal venous insufficiency
- Special Populations. Special groups include, but are not limited to children, prisoners, pregnant women,fetuses, and cognitively impaired individuals who are unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Synergy Health Concepts, Inc.
Newport Beach, California, 92660
Frances Debarge-Igoe, RN, 949-221-0129
John Joseph Hewett, MD
About this study
To establish if there are venous obstructions in patients with neurodegenerative disorders
Read the detailed description
This research registry will observe the venous obstruction in neurodegenerative disorders. This will provide data that will allow researchers to classify abnormal valve and venous morphology, distinguish vessels which are more responsive to treatment, determine groups who respond more favorably to treatment, and overall evaluate the outcomes of venous angioplasty in various neurodegenerative disorders that involve venous obstruction.
- Keywords
- CCSVI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2012 (estimated)
- Study startAug 2011
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Cerebral Spinal Venous InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Synergy Health Concepts, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Joseph Hewett, MD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01593358
- Sponsor's protocol ID
- RESEARCH_REGISTRY
- Status last verified
- May 2012
- First submitted
- 5 May 2012
- Last updated
- 8 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venous Obstruction in Neurodegenerative Disorders Research Registry
- ClinicalTrials.gov ID
- NCT01593358
- Acronym / sponsor ID
- RESEARCH_REGISTRY
- Keywords
- CCSVI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Synergy Health Concepts, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Study completion
- Jan 2014 (estimated)
- First posted
- 8 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To establish if there are venous obstructions in patients with neurodegenerative disorders
Detailed description
This research registry will observe the venous obstruction in neurodegenerative disorders. This will provide data that will allow researchers to classify abnormal valve and venous morphology, distinguish vessels which are more responsive to treatment, determine groups who respond more favorably to treatment, and overall evaluate the outcomes of venous angioplasty in various neurodegenerative disorders that involve venous obstruction.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Human subjects will be approached for participation in this registry that are receiving or seeking medical care at Synergy Health Concepts, Inc.No individuals shall be excluded from participation in the Research Registry based on race, ethnicity, or gender.
Key inclusion criteria (3 listed)
- Ability to comprehend the nature of the study, including the risks and benefits and execute an informed consent
- Males or Females between the ages of 18 and 90 years of age
- Voluntary agreement to participate in the Venous Obstructions in Neurodegenerative Diseases Research Registry
Key exclusion criteria (4 listed)
- Any implantable/metallic objects that prevent subject from having a magnetic resonance imaging ( MRI/MRV) study
- History of uncontrolled hypertension
- Previous venous angioplasty treatment for Chronic cerebral spinal venous insufficiency
- Special Populations. Special groups include, but are not limited to children, prisoners, pregnant women,fetuses, and cognitively impaired individuals who are unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Joseph Hewett, MD principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Cerebral Spinal Venous Insufficiency, run by Synergy Health Concepts, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frances DeBarge-Igoe, RN ((949) 221-0129, uscangionurse@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2012.