NCT06988449

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 23, 2025

Completed
Last Updated

May 23, 2025

Status Verified

May 1, 2025

Enrollment Period

2.6 years

First QC Date

May 16, 2025

Last Update Submit

May 16, 2025

Conditions

Tongue Neoplasms

Keywords

tongue defectreconstructionPolylactide membrane

Outcome Measures

Primary Outcomes (1)

  • Pain score

    5 days

Study Arms (1)

Tongue defect covered with ST250

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In hospital patients

You may qualify if:

  • lateral tunge defects (postoncologic resection)

You may not qualify if:

  • radio / chemotherapy
  • pregnant/ breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MarienHospital

Stuttgart, Baden-Wurttemberg, Germany

Location

Related Publications (1)

  • 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.

    PMID: 36452650BACKGROUND

Related Links

MeSH Terms

Conditions

Tongue Neoplasms

Condition Hierarchy (Ancestors)

Mouth NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic DiseasesTongue Diseases

Study Officials

  • Dorothee Rickert, PhD

    Marienhospital Stuttgart

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
A. Professor

Study Record Dates

First Submitted

May 16, 2025

First Posted

May 23, 2025

Study Start

July 1, 2022

Primary Completion

January 30, 2025

Study Completion

March 30, 2025

Last Updated

May 23, 2025

Record last verified: 2025-05

Locations

DE(1)