Use of ST250 to Reconstruct Lateral Tongue Defects | NCT06988449

Studies
Use of ST250 to Reconstruct Lateral Tongue Defects

NCT06988449

Sponsor

Cairo University

Status

Completed

Last Update Posted

May 23, 2025Actual

Enrollment

10Actual

Phase

Not provided

Conditions

Tongue Neoplasms

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2022Actual

Primary Completion Date

Jan 30, 2025Actual

Completion Date

Mar 30, 2025Actual

First Submitted Date

May 16, 2025

First Submission Date that Met QC Criteria

May 16, 2025

First Posted Date

May 23, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 16, 2025

Last Update Posted Date

May 23, 2025Actual

Name	Class
Marienhospital Stuttgart	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Label	Type	Description	Intervention Names
Tongue defect covered with ST250

Measure	Description	Time Frame
Pain score		5 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

lateral tunge defects (postoncologic resection)

Exclusion Criteria:

radio / chemotherapy
pregnant/ breastfeeding women

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

In hospital patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dorothee Rickert, PhD	Marienhospital Stuttgart	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MarienHospital		Stuttgart	Baden-Wurttemberg		Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36452650	Background	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.

ID	Term
D009062	Mouth Neoplasms
D006258	Head and Neck Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms