Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-24 @ 3:02 PM
NCT ID:
NCT05385159
Eligibility Criteria:
Inclusion Criteria:
* Subscription to the French Social Security System
* signed informed consent;
* voice Handicap Index \> 50/120;
* scarred vocal folds, congenital (sulcus) or after phonosurgery;
* scarred middle third in videolaryngostroboscopy;
* at least six-months delay after initial surgery if appropriate;
* patients aged between 18 and 70;
* good general condition;
* negative pregnancy test \& contraception for women of child-bearing age.
Exclusion Criteria:
* Refusal of speech therapy;
* history of malignant lesion or severe dysplasia of the scarred vocal fold;
* history of laryngeal papillomatosis;
* contraindication to local anesthesia;
* anti-coagulant treatment;
* coagulation disorders (Prothrombin Ratio \<65%, Activated Partial Thromboplastin Time \>1,2);
* active infectious diseases;
* any active viral infection from among the following: HIV, HTLV I and II, VHB, VHC and Syphilis;
* known sensitivity to human serum albumin (HSA);
* necessity of intraoperative prophylactic antibiotics;
* BMI \< 18 kg/m2 to insure adequate abdominal or other subcutaneous adipose tissue accessible to lipoharvest.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05385159
Study Brief:
Protocol Section:
NCT05385159