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Static Images and Facial Videos for Cleft Palate

N/A

Recruiting

Led By Carroll Ann Trotman

Research Sponsored by Tufts University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 4 to 21 years

Presence of a previously repaired unilateral or bilateral cleft lip and palate with a complete cleft of the primary palate and at least a partial or complete cleft of the secondary palate

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 2 years

Awards & highlights

Study Summary

This trial is testing how well surgeons can use objective measures and visual aids to make decisions during surgery.

Who is the study for?

This trial is for individuals aged 4 to 21 with a previously repaired unilateral or bilateral cleft lip and palate, including a complete cleft of the primary palate and at least a partial cleft of the secondary palate. Candidates must be recommended for lip revision surgery by their craniofacial plastic surgeon.Check my eligibility

What is being tested?

The study aims to understand how surgeons use visual aids like static images and facial videos alongside objective measures in decision-making for cleft lip surgery. It involves comparing different approaches using patient cohorts undergoing lip repair or revision surgeries.See study design

What are the potential side effects?

Since this trial focuses on evaluating decision-making processes rather than medical treatments, it does not involve direct side effects from interventions like drugs or devices.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 4 and 21 years old.

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I had surgery to repair a cleft lip and palate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Lip structure

Secondary outcome measures

Lip structure

Trial Design

1Treatment groups

Experimental Treatment

Group I: Static Images and Facial VideosExperimental Treatment1 Intervention

2D and 3D still and video images obtained from each patient before surgery.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalOTHER

2,935 Previous Clinical Trials

13,198,593 Total Patients Enrolled

Wake Forest University Health SciencesOTHER

1,243 Previous Clinical Trials

1,004,682 Total Patients Enrolled

Boston Children's HospitalOTHER

761 Previous Clinical Trials

5,579,882 Total Patients Enrolled

2 Trials studying Cleft Palate

83 Patients Enrolled for Cleft Palate

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still open slots for enrolment in this research effort?

"Affirmative, the data on clinicaltrials.gov verifies that this research trial is actively enrolling patients. The first posting was made on January 31st 2018 with the most recent update being December 18th 2023. This study requires 48 participants across 2 sites to complete its requirements."

Answered by AI

Are persons aged 40 or more eligible for this experiment?

"The requirements for applicants to this trial are that they must be between 0 months and 21 years old. There is an abundance of studies targeting those under 18, with 29 dedicated investigations, however only 5 studies intended for individuals over 65."

Answered by AI

How extensive is the participant population for this research endeavor?

"Correct. On clinicaltrials.gov, the trial is reported as being active with recruitment for 48 patients across 2 locations since its debut in January 31st 2018 and most recent update on December 18th 2023."

Answered by AI

Is it possible for me to join this research endeavor?

"This clinical trial seeks 48 participants with cleft palate, aged 0 months to 21 years. Other prerequisites include: 4-21 year old patients that have undergone corrective surgery for unilateral or bilateral primary and secondary palatal fissures and the professional recommendation of a craniofacial plastic surgeon for full/partial thickness lip revision."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Targeting Surgeons' Decision-Making for Cleft Lip Surgery

Carroll Ann Trotman 2018. "Targeting Surgeons' Decision-Making for Cleft Lip Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03537976.