TerminatedNot Applicable

DynaCleft® Effects on Soft Tissues and on Quality of Life for Incomplete Unilateral Cleft Lip Infants

Stopped: PI left institution

United States24 participantsStarted 2020-09-21

Plain-language summary

The purpose of this study is to examine the effectiveness of the DynaCleft® system on soft tissues of infants with unilateral incomplete cleft lip and to assess influences on quality of life for infants who underwent DynaCleft® and that of their families.

Who can participate

Age range

6 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Retrospective Group: * Unilateral cleft lip with or without cleft palate * Patients of a single surgeon (Matthew Greives, MD) * Patients with complete photographs: * After birth, first visit * At cleft lip repair (3-4 months) * Post-operative cleft repair (about 1 year of age) Prospective Group: * Patients with incomplete unilateral cleft lip with or without cleft palate * Patients of any surgeon Exclusion Criteria: Retrospective Group: * Bilateral cleft lip or complete unilateral cleft lip * Patients operated on by other primary surgeons * Patients with incomplete photo records will be evaluated to determine if the patient should be excluded Prospective Group: * Patients with bilateral cleft lip or complete unilateral cleft lip * Patients whose parents refuse to consent to inclusion * Patients with tape allergies to the adhesive of the DynaCleft® * Patients with syndromic craniofacial conditions or Tessier type facial clefts

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in Soft Tissue as Indicated by Width of the Cleft Lip Measured From Extraoral Clinical Photographs

Timeframe: initial time of examination with study team, time of surgery (3 months post intervention)

Changes in Soft Tissue as Indicated by Columellar Angle Measured From Extraoral Clinical Photographs

Timeframe: initial time of examination with study team, time of surgery (3 months post intervention)

Changes in Soft Tissue as Indicated by Nostril Height Measured From Extraoral Clinical Photographs

Timeframe: initial time of examination with study team, time of surgery (3 months post intervention)

Changes in Soft Tissue as Indicated by Nostril Width Measured From Extraoral Clinical Photographs

Timeframe: initial time of examination with study team, time of surgery (3 months post intervention)

Trial details

NCT IDNCT04455035

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-04-06

Results submitted2022-03-31

View on ClinicalTrials.gov More Cleft Lip and Palate trials