CraniosynostosisNCT00769847
Endoscopic Treatment for Isolated, Single Suture Craniosynostosis
An observational study of Craniosynostosis, run by University of Utah.
Trial summary
This is a prospective study to evaluate outcomes in patients undergoing endoscopic craniectomy for isolated, single-suture craniosynostosis. Read more about this study
- Who is it for?
- Ages 1 month to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Craniosynostosis
- What is being tested?
- Endoscopic strip craniectomy
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Sep 2013
- 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 1 month to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Male and female infants, from 1 to 6 months of age with isolated, single-suture sagittal craniosynostosis.
Who may be able to join
- Infants 1 to 6 months of age with isolated, single-suture craniosynostosis.
Who cannot join
- Multiple suture craniosynostosis and infants older than 6 months of age.
About this study
This is a prospective study to evaluate outcomes in patients undergoing endoscopic craniectomy for isolated, single-suture craniosynostosis.
- Conditions
- Craniosynostosis
- Being tested
- Endoscopic strip craniectomy
- Keywords
- Endoscopic, craniosynostosis, sagittal, synostosis
- Medical subject headings
- Craniosynostoses, Synostosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic strip craniectomyProcedure or surgery
Surgery
| Study group | Role | What they receive |
|---|---|---|
| Sagittal synostosis | Male and female infants from 1-6 months of age with isolated, single suture sagittal craniosynostosis. Receives: Procedure: Endoscopic strip craniectomy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionJul 2009
- Study completionSep 2013 (estimated)
Why it stopped: Study was withdrawn due to lack of resources.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for CraniosynostosisStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Investigators
- Faizi Siddiqu, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00769847
- Sponsor's protocol ID
- 22034
- Status last verified
- May 2015
- First submitted
- 7 Oct 2008
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Obrien MO, Johnson M: Craniosynostosis, in Youmans JR (ed): Neurological Surgery, Philadelphia: WB Saunders, 1990, Vol 2, p 1328.
HAAS LL. Roentgenological skull measurements and their diagnostic applications. Am J Roentgenol Radium Ther Nucl Med. 1952 Feb;67(2):197-209. No abstract available.
PubMed 14903268Lannelongue M. De la craniectomie dans la microcephalie. Compt Rend Seances Acad Sci 50:1382-1385, 1890.
Lane LC. Pioneer craniectomy for the relief of mental imbecility due to premature sutural closure and microcephalus. JAMA 18:49-50, 1892.
Panchal J, Marsh JL, Park TS, Kaufman B, Pilgram T, Huang SH. Sagittal craniosynostosis outcome assessment for two methods and timings of intervention. Plast Reconstr Surg. 1999 May;103(6):1574-84. doi: 10.1097/00006534-199905060-00004.
PubMed 10323690Jimenez DF, Barone CM. Endoscopic craniectomy for early surgical correction of sagittal craniosynostosis. J Neurosurg. 1998 Jan;88(1):77-81. doi: 10.3171/jns.1998.88.1.0077.
PubMed 9420076Jimenez DF, Barone CM, McGee ME, Cartwright CC, Baker CL. Endoscopy-assisted wide-vertex craniectomy, barrel stave osteotomies, and postoperative helmet molding therapy in the management of sagittal suture craniosynostosis. J Neurosurg. 2004 May;100(5 Suppl Pediatrics):407-17. doi: 10.3171/ped.2004.100.5.0407.
PubMed 15287447Murad GJ, Clayman M, Seagle MB, White S, Perkins LA, Pincus DW. Endoscopic-assisted repair of craniosynostosis. Neurosurg Focus. 2005 Dec 15;19(6):E6. doi: 10.3171/foc.2005.19.6.7.
PubMed 16398483
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Treatment for Isolated, Single Suture Craniosynostosis
- ClinicalTrials.gov ID
- NCT00769847
- Acronym / sponsor ID
- 22034
- Conditions
- Craniosynostosis
- Keywords
- Endoscopic, craniosynostosis, sagittal, synostosis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study was withdrawn due to lack of resources.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Sep 2013 (estimated)
- First posted
- 9 Oct 2008 (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 outcomes in patients undergoing endoscopic craniectomy for isolated, single-suture craniosynostosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sagittal synostosis | – | Procedure: Endoscopic strip craniectomyMale and female infants from 1-6 months of age with isolated, single suture sagittal craniosynostosis. |
Who may qualify
- Ages
- 1 month to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Male and female infants, from 1 to 6 months of age with isolated, single-suture sagittal craniosynostosis.
Key inclusion criteria (1 listed)
- Infants 1 to 6 months of age with isolated, single-suture craniosynostosis.
Key exclusion criteria (1 listed)
- Multiple suture craniosynostosis and infants older than 6 months of age.
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 |
|---|---|---|
| Endoscopic strip craniectomySurgery | Procedure or surgery | Sagittal synostosis |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
- BackgroundObrien MO, Johnson M: Craniosynostosis, in Youmans JR (ed): Neurological Surgery, Philadelphia: WB Saunders, 1990, Vol 2, p 1328.
- Background: PubMed 14903268HAAS LL. Roentgenological skull measurements and their diagnostic applications. Am J Roentgenol Radium Ther Nucl Med. 1952 Feb;67(2):197-209. No abstract available.
- BackgroundLannelongue M. De la craniectomie dans la microcephalie. Compt Rend Seances Acad Sci 50:1382-1385, 1890.
- BackgroundLane LC. Pioneer craniectomy for the relief of mental imbecility due to premature sutural closure and microcephalus. JAMA 18:49-50, 1892.
- Background: PubMed 10323690Panchal J, Marsh JL, Park TS, Kaufman B, Pilgram T, Huang SH. Sagittal craniosynostosis outcome assessment for two methods and timings of intervention. Plast Reconstr Surg. 1999 May;103(6):1574-84. doi: 10.1097/00006534-199905060-00004.
- Background: PubMed 9420076Jimenez DF, Barone CM. Endoscopic craniectomy for early surgical correction of sagittal craniosynostosis. J Neurosurg. 1998 Jan;88(1):77-81. doi: 10.3171/jns.1998.88.1.0077.
- Background: PubMed 15287447Jimenez DF, Barone CM, McGee ME, Cartwright CC, Baker CL. Endoscopy-assisted wide-vertex craniectomy, barrel stave osteotomies, and postoperative helmet molding therapy in the management of sagittal suture craniosynostosis. J Neurosurg. 2004 May;100(5 Suppl Pediatrics):407-17. doi: 10.3171/ped.2004.100.5.0407.
- Background: PubMed 16398483Murad GJ, Clayman M, Seagle MB, White S, Perkins LA, Pincus DW. Endoscopic-assisted repair of craniosynostosis. Neurosurg Focus. 2005 Dec 15;19(6):E6. doi: 10.3171/foc.2005.19.6.7.
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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.
Faizi Siddiqu, MD principal investigator
University of Utah
Questions about this trial
What is this clinical trial studying?
An observational study of Craniosynostosis, run by University of Utah.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 2 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00769847, which also lists 8 linked publications.
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 2 Jun 2015.