CerebroSpinal Fluid (CSF) LeakCBCT-ENTNCT01855425
Cone Beam CT for Diagnosis of Select Otorhinolaryngology (ENT) Indications at Lower Dose
A study testing Radiation in people with CerebroSpinal Fluid (CSF) Leak and Chronic Otitis Media, run by Carestream Health, Inc. at 3 sites in 3 countries.
Trial summary
The study objective is to compare the CBCT images generated by the CS 9300 to those generated by conventional CT. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- CerebroSpinal Fluid (CSF) Leak, Chronic Otitis Media, Otospongiosis
- What is being tested?
- Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 21 Sep 2012to 9 Aug 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be 18-80 years of age
- Subjects has provided informed consent
- Subjects must present with symptoms and/or pathology of the sinus or temporal bone region.
- Subject scheduled for additional radiological follow-up and/or endoscopy/surgery.
- CBCT exam performed within a maximum of 2 days of the conventional CT.
Who cannot join
- Subjects under the age of 18 years, or over the age of 80 years
- Unable to collect all required case information
- Subjects not willing to consent, or consent is withdrawn
- Women in pregnancy or suspected of being pregnant confirmed by pregnancy test
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United States1 site
Johns Hopkins Medical Center
Baltimore, Maryland, 21287
About this study
Official title: Cone Beam CT (CS 9300) for Diagnosis of Select Otorhinolaryngology (ENT) Indications at Lower Dose
The study objective is to compare the CBCT images generated by the CS 9300 to those generated by conventional CT.
Read the detailed description
The study objective is to compare the CBCT images generated by the CS 9300 to those generated by conventional CT. It proposes a direct comparison of diagnostic image quality between the CS 9300 and CT for the ability to view and confirm ENT disorders.
- Conditions
- CerebroSpinal Fluid (CSF) Leak, Chronic Otitis Media, Otospongiosis, Otosclerosis, Pulsatile Tinnitus, Cholesteatoma
- Being tested
- Radiation
- Medical subject headings
- Otosclerosis, Tinnitus, Cholesteatoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiationRadiation
Subjects to receive standard of care CT scan and additional Cone Beam CT scan.
| Study group | Role | What they receive |
|---|---|---|
| Investigational CBCT | Other | Radiation Receives: Radiation: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With >=3 Diagnostic Rating Using Radlex Scale
Percentage of Participants with >=3 Diagnostic Rating Using Radlex Scale. Five radiologists participated in reader study using Radlex scale below to analyze and rate participant images. They determined if they could make a medical diagnosis for ENT patients.
Used Radlex Scale - 1-Non-diagnostic, Unacceptable for diagnostic purposes. 2-Limited Acceptable, with some technical defect. 3-Diagnostic, Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary, Good most adequate for diagnostic purposes.
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2013 (estimated)
- Study start21 Sep 2012
- Primary completion9 Aug 2013
- Study completion9 Aug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CerebroSpinal Fluid (CSF) LeakStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Predicate CT Scan and Investigational Cone Beam Scan
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carestream Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Douglas Reh, MD, Principal investigator, Johns Hopkins Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01855425
- Sponsor's protocol ID
- 6K0377
- Acronym
- CBCT-ENT
- Status last verified
- Jul 2018
- First submitted
- 6 May 2013
- Last updated
- 28 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cone Beam CT (CS 9300) for Diagnosis of Select Otorhinolaryngology (ENT) Indications at Lower Dose
- ClinicalTrials.gov ID
- NCT01855425
- Acronym / sponsor ID
- CBCT-ENT / 6K0377
- Conditions
- CerebroSpinal Fluid (CSF) Leak, Chronic Otitis Media, Otospongiosis, Otosclerosis, Pulsatile Tinnitus, Cholesteatoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Carestream Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Sep 2012 (actual)
- Primary completion
- 9 Aug 2013 (actual)
- Study completion
- 9 Aug 2013 (actual)
- First posted
- 16 May 2013 (estimated)
- Results
- Posted 1 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study objective is to compare the CBCT images generated by the CS 9300 to those generated by conventional CT.
Detailed description
The study objective is to compare the CBCT images generated by the CS 9300 to those generated by conventional CT. It proposes a direct comparison of diagnostic image quality between the CS 9300 and CT for the ability to view and confirm ENT disorders.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Predicate CT Scan and Investigational Cone Beam Scan
| Arm | Type | Receives |
|---|---|---|
| Investigational CBCT | Other | Radiation: RadiationRadiation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject must be 18-80 years of age
- Subjects has provided informed consent
- Subjects must present with symptoms and/or pathology of the sinus or temporal bone region.
- Subject scheduled for additional radiological follow-up and/or endoscopy/surgery.
- CBCT exam performed within a maximum of 2 days of the conventional CT.
Key exclusion criteria (4 listed)
- Subjects under the age of 18 years, or over the age of 80 years
- Unable to collect all required case information
- Subjects not willing to consent, or consent is withdrawn
- Women in pregnancy or suspected of being pregnant confirmed by pregnancy test
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 |
|---|---|---|
| RadiationSubjects to receive standard of care CT scan and additional Cone Beam CT scan. | Radiation | Investigational CBCT |
Primary outcome
Percentage of Participants With >=3 Diagnostic Rating Using Radlex Scale
Time frame: 11 months
Percentage of Participants with >=3 Diagnostic Rating Using Radlex Scale. Five radiologists participated in reader study using Radlex scale below to analyze and rate participant images. They determined if they could make a medical diagnosis for ENT patients. Used Radlex Scale - 1-Non-diagnostic, Unacceptable for diagnostic purposes. 2-Limited Acceptable, with some technical defect. 3-Diagnostic, Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary, Good most adequate for diagnostic purposes.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for CerebroSpinal Fluid (CSF) Leak
Not yet recruiting
A Prospective, Randomized, Two-Arm, Controlled, Single-Blind, Multi-Center Study to Evaluate the Safety and Efficacy of ArtiFix® Dural Repair Sealant Graft in Cranial and Spine Surgery (NEOFIX Study)
CerebroSpinal Fluid (CSF) Leak, Dural Tear
Recruiting
Conservative vs Interventional Management of Postsurgical CSF Pseudomeningocele
CSF Leak, CSF Pressure Increased
Recruiting
Evaluation of Internal Nasal Splint-Supported Free Graft Versus Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks
CSF Leak
RecruitingObservational study
Analysis of Cerebrospinal Fluid Leakage After Surgery for Intracranial Tumors
Brain Tumor Adult, Brain Tumor Benign
RecruitingPhase 2
Efficacy and Safety Evaluation of Absorbable and Moldable Skull Base Support Plates in Extended Endoscopic Endonasal Transsphenoidal Surgery: A Prospective, Randomized, Controlled Study
Sellar Tumor, Endonasal Surgery
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.
Douglas Reh, MD principal investigator
Johns Hopkins Medical Center
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation in people with CerebroSpinal Fluid (CSF) Leak and Chronic Otitis Media, run by Carestream Health, Inc. at 3 sites in 3 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 5 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: finished, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Belgium, France. 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?
Yes. Results are posted in the registry (first posted 1 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With >=3 Diagnostic Rating Using Radlex Scale (time frame: 11 months). 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 Aug 2018.