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CompletedNCT06988449Updated May 23, 2025

Use of ST250 to Reconstruct Lateral Tongue Defects

An observational study in Tongue Neoplasms, sponsored by Cairo University. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-23.

Sponsored by Cairo University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
18 Years and older
Sex
All
01

Study summary

To assess the use of SupraThel 250 for mucosal reconstruction in the Head \& Neck region. The membrane is applied to reconstruct lateral tongue defects . healing of the mucosa and regaining of normal tongue movement and speech are assessed postoperatively.

Read the detailed description

Lateral tongue defects are usually treated using radial fore-arm free grafts which require a prolonged hospital stay with higher morbidity rates. It also entails the need of multiple rehabilitation and remodeling porcdures of the transplnted flap to enable intelligible speech and tongue function.

02

Conditions studied

  • Tongue Neoplasms

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Keywords

  • tongue defect
  • reconstruction
  • Polylactide membrane
03

In context

Tongue Neoplasms

85 studies on the registry are indexed under Tongue Neoplasms; 13 are open to participants now.

This study's enrollment of 10 is below the median of 50 across 11 observational studies indexed under Tongue Neoplasms.

Browse Tongue Neoplasms studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

In hospital patients

Inclusion criteria

  • lateral tunge defects (postoncologic resection)

Exclusion criteria

Exclusion Criteria:

  • radio / chemotherapy
  • pregnant/ breastfeeding women
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (actual)
Patient registry
No

Groups and cohorts

  • Tongue defect covered with ST250
06

What researchers measure

Primary outcomes

  1. Pain score

    Time frame: 5 days

07

Study locations

1 site
  • MarienHospital
    Stuttgart, Baden-Wurttemberg, Germany
08

References and documents

Publications

  • Sarin V, Chatterjee A, Kakkar V, Juneja A. Evaluation of Tongue Functions After Free Flap Reconstruction. Indian J Otolaryngol Head Neck Surg. 2022 Oct;74(Suppl 2):2398-2403. doi: 10.1007/s12070-020-02177-1. Epub 2020 Oct 8. PubMed 36452650 ↗

Related links

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06988449
Lead sponsor
Cairo University
Collaborators
Marienhospital Stuttgart
Responsible party
Alaa Emara (A. Professor, Cairo University) — Principal investigator
First posted
May 23, 2025
Start date
Jul 1, 2022
Primary completion
Jan 30, 2025
Completion
Mar 30, 2025
Last update
May 23, 2025

Study contacts

Dorothee Rickert, PhD
principal investigator · Marienhospital Stuttgart

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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