Tongue NeoplasmsNCT06988449
Use of ST250 to Reconstruct Lateral Tongue Defects
An observational study of Tongue Neoplasms, run by Cairo University at 1 site in Germany.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tongue Neoplasms
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2022to 30 Mar 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In hospital patients
Who may be able to join
- lateral tunge defects (postoncologic resection)
Who cannot join
- radio / chemotherapy
- pregnant/ breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Tongue Neoplasms
- Keywords
- tongue defect, reconstruction, Polylactide membrane
- Medical subject headings
- Tongue Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tongue defect covered with ST250 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start1 Jul 2022
- Primary completion30 Jan 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tongue NeoplasmsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Marienhospital Stuttgart
- Responsible party
- Principal investigator, Alaa Emara, Cairo University
- Investigators
- Dorothee Rickert, PhD, Principal investigator, Marienhospital Stuttgart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06988449
- Sponsor's protocol ID
- ST250 for tongue defect
- Status last verified
- May 2025
- First submitted
- 16 May 2025
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of ST250 to Reconstruct Lateral Tongue Defects
- ClinicalTrials.gov ID
- NCT06988449
- Acronym / sponsor ID
- ST250 for tongue defect
- Conditions
- Tongue Neoplasms
- Keywords
- tongue defect, reconstruction, Polylactide membrane
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Marienhospital Stuttgart
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 23 May 2025 (actual)
- 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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tongue defect covered with ST250 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In hospital patients
Key inclusion criteria (1 listed)
- lateral tunge defects (postoncologic resection)
Key exclusion criteria (2 listed)
- radio / chemotherapy
- pregnant/ breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain score
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Background: PubMed 36452650Sarin 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Dorothee Rickert, PhD principal investigator
Marienhospital Stuttgart
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 Tongue Neoplasms, run by Cairo University at 1 site in Germany.
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 2 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: finished, as of the sponsor's last update on 23 May 2025. 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 Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain score (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06988449, which also lists 1 linked publication.
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 23 May 2025.