Cerebrospinal Fluid LeakageNCT01295619
Performance and Safety of I-020805 in Prevention of Cerebrospinal Fluid (CSF) Leakage Following Elective Craniotomy
A study testing I-020805 in people with Cerebrospinal Fluid Leakage, run by Kuros Biosurgery AG at 4 sites in 2 countries.
Trial summary
This is a prospective study to evaluate the performance and safety of a new medical device used in case of cerebrospinal fluid (CSF) leakage after an elective cranial surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrospinal Fluid Leakage
- What is being tested?
- I-020805
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Feb 2011to Dec 2011
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pre-operative
- Male or female of 18 years old or over
- Elective cranial procedure entailing a dural incision of at least 2 cm in length
- Requires a procedure involving surgical wound classification Class I/Clean
- Signed informed consent form
- Negative pregnancy test at screening for women of childbearing potential and agreeing to use an acceptable birth control method or abstinence until 90 days post-surgery
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- Intra-operative
- Surgical wound classification Class I/Clean
- Dural margin from bony edges of at least 3 mm throughout
- Spontaneous expression of CSF assessed visually or a CSF leakage upon Valsalva maneuver
Who cannot join
- Pre-operative
- Cranial procedure requiring translabyrinthine, transoral and/or any procedure penetrating the air sinus or mastoid air cells
- Presence of symptomatic hydrocephalus
- Pre-existing external ventricular drainage or lumbar CSF drain
- Radiotherapy in the planned surgical region which ended within 3 months prior to planned surgery
- Presence of systemic infection
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- Known history of hemophilia or other clinically significant coagulopathy
- Known oral anticoagulant use
- Pregnancy or breast feeding
- Known allergy to any components of I-020805
- Previous participation in this trial or any investigational drug or device study within 30 day of screening
- Known clinically significant organ or systemic diseases
- Known or suspected non-compliance with trial procedures
- Intra-operative
- Patient not meeting the pre-operative eligibility criteria
- Not able to tolerate a Valsalva maneuver
- Gap of more than 2 mm remaining after primary closure of dura
- Use of synthetic or non-autologous duraplasty material
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Hungary3 sites
Orszagos Idegtudomanyi Intezet (11)
Budapest, 1145
Debreceni Tudomanyegyetem (12)
Debrecen, 4023
Szegedi Tudomanyegyetem (10)
Szeged, 6725
About this study
Official title: A Prospective, Open, Multi-center, Single-arm Study of the Performance and Safety of I-020805 in the Prevention of Cerebrospinal Fluid Leakage Following Elective Cranial Surgery
This is a prospective study to evaluate the performance and safety of a new medical device used in case of cerebrospinal fluid (CSF) leakage after an elective cranial surgery.
Read the detailed description
Patients who consented to participate in the trial and fulfilled the preoperative inclusion and exclusion criteria underwent screening prior to surgical treatment. After dural suturing, if patients met the intra operative inclusion and exclusion criteria, they received I-020805. If necessary, autologous grafts were to be used to augment dural closure.
I-020805 was delivered from a double syringe applicator that creates a fine layer over the dura. This layer quickly sets within seconds to form a watertight seal.
- Conditions
- Cerebrospinal Fluid Leakage
- Being tested
- I-020805
- Keywords
- Dura, Sealant, Cranial, Craniotomy, CSF leakage, CSF leakage following cranial surgery
- Medical subject headings
- Cerebrospinal Fluid Leak, Cerebrospinal Fluid Rhinorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-020805Device
A thin layer of I-020805 applied up to two times on the sutured dura mater
| Study group | Role | What they receive |
|---|---|---|
| I-020805 | Experimental | This was a prospective, open, multi-center, single-arm study to investigate I-020805 in patients following elective cranial surgery. If they met the inclusion/ exclusion criteria, they receive I-020805 after suturing of the dura. If necessary, autologous grafts were to be used to augment dural closure. Receives: Device: I-020805 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of I-020805 in prevention of CSF leakage
Measured: Intraoperative on the day of sugery
Secondary outcomes (6)
Incidence of CSF leakage
Measured: Within 7 days after surgery or prior to discharge
CSF leakage or pseudomeningocele related surgical intervention
Measured: Within 90 days following surgery
CSF leakage confirmed by clinical evaluation or diagnostic testing
Measured: Within 90 days following surgery
Surgical infection and unexpected neurological signs
Measured: Post-operative and within 7 days and 90 following surgery
Wound healing impairment
Measured: Throughout study up to 90 days following surgery
Incidence of all and treatment emergent adverse events
Measured: Throughout study up to 90 days following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrospinal Fluid LeakageStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuros Biosurgery AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Virginia Jamieson, MD, Study director, Kuros Biosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01295619
- Sponsor's protocol ID
- CS I-020805/01
- Status last verified
- Nov 2016
- First submitted
- 9 Feb 2011
- Last updated
- 28 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open, Multi-center, Single-arm Study of the Performance and Safety of I-020805 in the Prevention of Cerebrospinal Fluid Leakage Following Elective Cranial Surgery
- ClinicalTrials.gov ID
- NCT01295619
- Acronym / sponsor ID
- CS I-020805/01
- Conditions
- Cerebrospinal Fluid Leakage
- Keywords
- Dura, Sealant, Cranial, Craniotomy, CSF leakage, CSF leakage following cranial surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Kuros Biosurgery AGIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 14 Feb 2011 (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.
This is a prospective study to evaluate the performance and safety of a new medical device used in case of cerebrospinal fluid (CSF) leakage after an elective cranial surgery.
Detailed description
Patients who consented to participate in the trial and fulfilled the preoperative inclusion and exclusion criteria underwent screening prior to surgical treatment. After dural suturing, if patients met the intra operative inclusion and exclusion criteria, they received I-020805. If necessary, autologous grafts were to be used to augment dural closure.
I-020805 was delivered from a double syringe applicator that creates a fine layer over the dura. This layer quickly sets within seconds to form a watertight seal.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I-020805 | Experimental | Device: I-020805This was a prospective, open, multi-center, single-arm study to investigate I-020805 in patients following elective cranial surgery. If they met the inclusion/ exclusion criteria, they receive I-020805 after suturing of the dura. If necessary, autologous grafts were to be used to augment dural closure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Pre-operative
- Male or female of 18 years old or over
- Elective cranial procedure entailing a dural incision of at least 2 cm in length
- Requires a procedure involving surgical wound classification Class I/Clean
- Signed informed consent form
Key exclusion criteria (18 listed)
- Pre-operative
- Cranial procedure requiring translabyrinthine, transoral and/or any procedure penetrating the air sinus or mastoid air cells
- Presence of symptomatic hydrocephalus
- Pre-existing external ventricular drainage or lumbar CSF drain
- Radiotherapy in the planned surgical region which ended within 3 months prior to planned surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-020805A thin layer of I-020805 applied up to two times on the sutured dura mater | Device | I-020805 |
Primary outcome
Performance of I-020805 in prevention of CSF leakage
Time frame: Intraoperative on the day of sugery
6 secondary outcomes
Incidence of CSF leakage
Time frame: Within 7 days after surgery or prior to discharge
CSF leakage or pseudomeningocele related surgical intervention
Time frame: Within 90 days following surgery
CSF leakage confirmed by clinical evaluation or diagnostic testing
Time frame: Within 90 days following surgery
Surgical infection and unexpected neurological signs
Time frame: Post-operative and within 7 days and 90 following surgery
Wound healing impairment
Time frame: Throughout study up to 90 days following surgery
Incidence of all and treatment emergent adverse events
Time frame: Throughout study up to 90 days following surgery
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 28 Nov 2016.
- Individual participant dataSharing planned: No
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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.
Virginia Jamieson, MD study director
Kuros Biosurgery
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I-020805 in people with Cerebrospinal Fluid Leakage, run by Kuros Biosurgery AG at 4 sites in 2 countries.
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 10 inclusion and 18 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 28 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Hungary, Germany. 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?
Performance of I-020805 in prevention of CSF leakage (time frame: Intraoperative on the day of sugery). It is what the study was designed to measure, not a finding.
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 28 Nov 2016.