Cerebral AneurysmsGel-the-necNCT01000675
Registry for Study of Coils in Intracranial Aneurysms
An observational study of Cerebral Aneurysms, run by Mayo Clinic at 1 site in United States.
Trial summary
The current proposal describes a post-market, clinical registry of HydroSoft, aimed at gaining robust clinical data in a large set of patients to better define the advantages, and potentially, the disadvantages of the HydroSoft, and to inform future randomized trials. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Cerebral Aneurysms
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Dec 2016
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All people with cerebral aneurysms between the ages of 21 and 90 that are treated with coils.
Who may be able to join
- Patient presenting with a ruptured or un-ruptured cerebral aneurysm appropriate for endovascular treatment as determined by the neurovascular team (neurosurgeon/neurointerventionist)
- Patient age: patients aged between 21 and 90 years will be eligible.
- Patient HUNT AND HESS Grade 0-3.
- Patient has given fully informed consent to endovascular coiling procedure or if patient cannot consent for themselves, appropriate written consent has been sought from their next of kin, or from appropriate power of attorney.
- Aneurysm 3-15mm in maximum diameter.
- Patient is willing and able to return for follow up angiography or MRA between 6-18 months.
- The patient has not been previously entered into this registry
- The aneurysm has not previously been treated (by coiling or clipping).
Who cannot join
- Inability to obtain informed consent.
- Medical or surgical comorbidity such that the patient's life expectancy is less than 1 year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gaining Efficacy Long Term: Hydrosoft, an Emerging, New, Embolic Coil (Gel-the-nec)
The current proposal describes a post-market, clinical registry of HydroSoft, aimed at gaining robust clinical data in a large set of patients to better define the advantages, and potentially, the disadvantages of the HydroSoft, and to inform future randomized trials.
Read the detailed description
Aim 1. (Primary Outcome) To test the hypothesis that HydroSoft coils lead to diminished rates of aneurysm recurrence relative to bare platinum coils. In order to test this hypothesis, we will compare recanalization or recurrence rates observed in this prospective registry of HydroSoft coils used as finishing coils to historical series of aneurysms treated with bare platinum coils. This registry is designed to achieve 80% power to detect a minimally clinically relevant difference in rates of recurrence between HydroSoft-treated aneurysms compared with bare platinum coils. Based on recent, prospective, randomized trials assessing both bare platinum coils and hydrogel-bearing coils with 25% and 15% recurrence rates, respectively, we predict a recurrence rate of 18% for HydroSoft treated aneurysms. Typically, a "minimally clinically relevant difference" is on the order of a 30% diminution in a given undesirable outcome. As such, the registry is well powered to detect this minimally clinically relevant difference (18% expected recurrence rate for HydroSoft treated coils versus 25% for the historical control group).
Aim 2. (Secondary Outcome 1) To test the hypothesis that the HydroSoft embolic coil can be placed reliably in intracranial, saccular aneurysms, even late in the embolization procedure. Success of this aim is defined as ease of placement of the HydroSoft device, without need for coil removal and subsequent "finishing" with a bare platinum coil.
Aim 3. (Secondary Outcome 2) To test the hypothesis that use of the HydroSoft embolic coil is associated with risks of thromboembolism similar to that with other coil types, on the order of 3-5% or less.
- Conditions
- Cerebral Aneurysms
- Keywords
- aneurysm, coils
- Medical subject headings
- Intracranial Aneurysm, Aneurysm
What is being measured
The primary outcome is the main question the study is designed to answer.
We will compare recanalization or recurrence rates observed in this prospective registry of HydroSoft coils used as finishing coils to historical series of aneurysms treated with bare platinum coils.
Measured: 6 - 18 months post coiling
Secondary outcomes (1)
HydroSoft embolic coil can be placed reliably in intracranial, saccular aneurysms, even late in the embolization procedure.
Measured: 6 - 18 months post coiling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2009 (estimated)
- Study startAug 2009
- Primary completionJun 2013
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral AneurysmsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott, Albany Medical College, Asan Medical Center, Baylor University, Bronson Methodist Hospital, Capital Health, Canada, The Cleveland Clinic, Dalhousie University, Fudan University, Fort Sanders Regional Medical Center, JFK Medical Center, Florida, Kobe City Medical Center, Methodist Research Institute, Indianapolis, Medical University of South Carolina, Providence Health & Services, Scott and White Hospital & Clinic, Stony Brook University, Thomas Jefferson University, Royal University Hospital Foundation, University of California, Los Angeles, University of Florida, University of Maryland, University of Oklahoma, University of Southern California, Washington University School of Medicine
- Responsible party
- Principal investigator, David F. Kallmes, Mayo Clinic
- Investigators
- David F Kallmes, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01000675
- Sponsor's protocol ID
- 09-002933
- Acronym
- Gel-the-nec
- Status last verified
- Jun 2019
- First submitted
- 22 Oct 2009
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Brinjikji W, Amar AP, Delgado Almandoz JE, Diaz O, Jabbour P, Hanel R, Hui F, Kelly M, Layton KD, Miller JW, Levy E, Moran C, Suh DC, Woo H, Sellar R, Ho B, Evans A, Kallmes DF. GEL THE NEC: a prospective registry evaluating the safety, ease of use, and efficacy of the HydroSoft coil as a finishing device. J Neurointerv Surg. 2018 Jan;10(1):83-87. doi: 10.1136/neurintsurg-2016-012915. Epub 2017 Jan 30.
PubMed 28138062
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gaining Efficacy Long Term: Hydrosoft, an Emerging, New, Embolic Coil (Gel-the-nec)
- ClinicalTrials.gov ID
- NCT01000675
- Acronym / sponsor ID
- Gel-the-nec / 09-002933
- Conditions
- Cerebral Aneurysms
- Keywords
- aneurysm, coils
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Abbott, Albany Medical College, Asan Medical Center, Baylor University, Bronson Methodist Hospital, Capital Health, Canada, The Cleveland Clinic, Dalhousie University, Fudan University, Fort Sanders Regional Medical Center, JFK Medical Center, Florida, Kobe City Medical Center, Methodist Research Institute, Indianapolis, Medical University of South Carolina, Providence Health & Services, Scott and White Hospital & Clinic, Stony Brook University, Thomas Jefferson University, Royal University Hospital Foundation, University of California, Los Angeles, University of Florida, University of Maryland, University of Oklahoma, University of Southern California, Washington University School of Medicine
- Study start
- Aug 2009 (actual)
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 23 Oct 2009 (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.
The current proposal describes a post-market, clinical registry of HydroSoft, aimed at gaining robust clinical data in a large set of patients to better define the advantages, and potentially, the disadvantages of the HydroSoft, and to inform future randomized trials.
Detailed description
Aim 1. (Primary Outcome) To test the hypothesis that HydroSoft coils lead to diminished rates of aneurysm recurrence relative to bare platinum coils. In order to test this hypothesis, we will compare recanalization or recurrence rates observed in this prospective registry of HydroSoft coils used as finishing coils to historical series of aneurysms treated with bare platinum coils. This registry is designed to achieve 80% power to detect a minimally clinically relevant difference in rates of recurrence between HydroSoft-treated aneurysms compared with bare platinum coils. Based on recent, prospective, randomized trials assessing both bare platinum coils and hydrogel-bearing coils with 25% and 15% recurrence rates, respectively, we predict a recurrence rate of 18% for HydroSoft treated aneurysms. Typically, a "minimally clinically relevant difference" is on the order of a 30% diminution in a given undesirable outcome. As such, the registry is well powered to detect this minimally clinically relevant difference (18% expected recurrence rate for HydroSoft treated coils versus 25% for the historical control group).
Aim 2. (Secondary Outcome 1) To test the hypothesis that the HydroSoft embolic coil can be placed reliably in intracranial, saccular aneurysms, even late in the embolization procedure. Success of this aim is defined as ease of placement of the HydroSoft device, without need for coil removal and subsequent "finishing" with a bare platinum coil.
Aim 3. (Secondary Outcome 2) To test the hypothesis that use of the HydroSoft embolic coil is associated with risks of thromboembolism similar to that with other coil types, on the order of 3-5% or less.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All people with cerebral aneurysms between the ages of 21 and 90 that are treated with coils.
Key inclusion criteria (8 listed)
- Patient presenting with a ruptured or un-ruptured cerebral aneurysm appropriate for endovascular treatment as determined by the neurovascular team (neurosurgeon/neurointerventionist)
- Patient age: patients aged between 21 and 90 years will be eligible.
- Patient HUNT AND HESS Grade 0-3.
- Patient has given fully informed consent to endovascular coiling procedure or if patient cannot consent for themselves, appropriate written consent has been sought from their next of kin, or from appropriate power of attorney.
- Aneurysm 3-15mm in maximum diameter.
Key exclusion criteria (2 listed)
- Inability to obtain informed consent.
- Medical or surgical comorbidity such that the patient's life expectancy is less than 1 year.
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
We will compare recanalization or recurrence rates observed in this prospective registry of HydroSoft coils used as finishing coils to historical series of aneurysms treated with bare platinum coils.
Time frame: 6 - 18 months post coiling
1 secondary outcome
HydroSoft embolic coil can be placed reliably in intracranial, saccular aneurysms, even late in the embolization procedure.
Time frame: 6 - 18 months post coiling
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Derived from this study: PubMed 28138062Brinjikji W, Amar AP, Delgado Almandoz JE, Diaz O, Jabbour P, Hanel R, Hui F, Kelly M, Layton KD, Miller JW, Levy E, Moran C, Suh DC, Woo H, Sellar R, Ho B, Evans A, Kallmes DF. GEL THE NEC: a prospective registry evaluating the safety, ease of use, and efficacy of the HydroSoft coil as a finishing device. J Neurointerv Surg. 2018 Jan;10(1):83-87. doi: 10.1136/neurintsurg-2016-012915. Epub 2017 Jan 30.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
David F Kallmes, MD principal investigator
Mayo Clinic
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 Cerebral Aneurysms, run by Mayo Clinic 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 8 inclusion and 2 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: finished, as of the sponsor's last update on 6 Jun 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
We will compare recanalization or recurrence rates observed in this prospective registry of HydroSoft coils used as finishing coils to historical series of aneurysms treated with bare platinum coils. (time frame: 6 - 18 months post coiling). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01000675, which also lists 1 linked publication.
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 6 Jun 2019.