Thoracic Insufficiency SyndromeNCT00585234
Tools for the Objective Clinical Assessment of Pediatric Spinal Deformity
An observational study of Thoracic Insufficiency Syndrome and TIS, run by University of Utah at 1 site in United States.
Trial summary
This project seeks to develop a standardized technique for simultaneous capturing bi-planar images of patients against a standard background with a grid that can be used later for the quantitative determination of global balance and thoracic symmetry. Read more about this study
- Who is it for?
- Ages 1 year to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Thoracic Insufficiency Syndrome, TIS
- What is being tested?
- Digital Photography
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Mar 2012
- 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 year to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Primary Care Center
Who may be able to join
- Male and female participants from 1- skeletal maturity
Who cannot join
- no specific disease related exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tools for Objective Clinical Assessment of Pediatric Spinal Deformity and the Results of Surgical Intervention--Simultaneous Measurement of Sagittal and Coronal Balance and Symmetry With Digital Photography.
This project seeks to develop a standardized technique for simultaneous capturing bi-planar images of patients against a standard background with a grid that can be used later for the quantitative determination of global balance and thoracic symmetry.
We hypothesize that patients who are successfully managed with surgery will demonstrate an improvement in global balance and thoracic symmetry that can be accurately measured. This measurement station will be specifically developed to provide a standardized, reproducible means to compare clinical assessments of surgical and non-surgical outcomes, and establish normative data for comparison. This standardized tool can be established at multiple centers for use in multicenter trials.
- Conditions
- Thoracic Insufficiency Syndrome, TIS
- Being tested
- Digital Photography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital PhotographyOther
Digital Photography
| Study group | Role | What they receive |
|---|---|---|
| 1 | We intend to photograph male and female subjects from age 1 through skeletal maturity. Healthy children will be photographed to determine the normative characteristics of thoracic function using this technique. We will also enroll patients with thoracic pathology to determine how digital imaging can document thoracic dysfunction. There are no specific disease related exclusion criteria. Participation is voluntary. Receives: Other: Digital Photography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in overall global balance following surgical intervention
Measured: Dec 2005-Dec 2008
Secondary outcomes (1)
Improvement in overall global balance
Measured: Dec 2005-Dec 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2008 (estimated)
- Study startDec 2005
- Primary completionMar 2012
- Study completionMar 2012
Why it stopped: Study has been withdrawn.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Insufficiency SyndromeStudies 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
- Responsible party
- Principal investigator, john t. smith, University of Utah
- Investigators
- John T Smith, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00585234
- Sponsor's protocol ID
- 00014137
- Other IDs
- IRB# 00014137
- Status last verified
- Jan 2024
- First submitted
- 21 Dec 2007
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tools for Objective Clinical Assessment of Pediatric Spinal Deformity and the Results of Surgical Intervention--Simultaneous Measurement of Sagittal and Coronal Balance and Symmetry With Digital Photography.
- ClinicalTrials.gov ID
- NCT00585234
- Acronym / sponsor ID
- 00014137
- Conditions
- Thoracic Insufficiency Syndrome, TIS
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study has been withdrawn.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 3 Jan 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 project seeks to develop a standardized technique for simultaneous capturing bi-planar images of patients against a standard background with a grid that can be used later for the quantitative determination of global balance and thoracic symmetry.
We hypothesize that patients who are successfully managed with surgery will demonstrate an improvement in global balance and thoracic symmetry that can be accurately measured. This measurement station will be specifically developed to provide a standardized, reproducible means to compare clinical assessments of surgical and non-surgical outcomes, and establish normative data for comparison. This standardized tool can be established at multiple centers for use in multicenter trials.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Digital PhotographyWe intend to photograph male and female subjects from age 1 through skeletal maturity. Healthy children will be photographed to determine the normative characteristics of thoracic function using this technique. We will also enroll patients with thoracic pathology to determine how digital imaging can document thoracic dysfunction. There are no specific disease related exclusion criteria. Participation is voluntary. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Primary Care Center
Key inclusion criteria (1 listed)
- Male and female participants from 1- skeletal maturity
Key exclusion criteria (1 listed)
- no specific disease related exclusion criteria
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 |
|---|---|---|
| Digital PhotographyDigital Photography | Other | 1 |
Primary outcome
Improvement in overall global balance following surgical intervention
Time frame: Dec 2005-Dec 2008
1 secondary outcome
Improvement in overall global balance
Time frame: Dec 2005-Dec 2008
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 9 Jan 2024.
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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.
John T Smith, MD principal investigator
University of Utah
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 Thoracic Insufficiency Syndrome and TIS, run by University of Utah 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 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 9 Jan 2024. 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 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.
What does the primary outcome measure?
Improvement in overall global balance following surgical intervention (time frame: Dec 2005-Dec 2008). 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 9 Jan 2024.