Kort-SGS: Does a series of cortison injections after balloon dilatation or laser treatment of subglottic stenosis prolong interval between surgical procedures? A prospective single blinded study

Phase 1

• Conditions: Subglottic stenosis: Idiopatic, autoimmune, traumatic.; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2018-000614-37-SE
• Lead Sponsor: Region Örebro Län

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-05
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1.= 18 - = 70 years old with subglottic stenosis ( ICD diagnose code J38.6, J38.7, J39.8, J95.5, J95.8) that will be treated surgically.
2.Able and willing to leave a written consent.
3.Able and willing to comply with
protocol procedures.
4. Have a symtomatic subglottic stenosis

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1.Stenosis caused by a malignant tumor, external preassure on the trachea (eg enlarged thyroid), post radiation effect in the mucous membrande and glotttic or supraglottic involvement.
2. Stenosis that does not respond to endoscopic surgery: deformed cartilage, either in cricoid cartilage and/or trachea. These types of subglottic stenosis are successfully treated with open surgery.
3. Women who are pregnant or nursing when surgery is schedule and during ongoing treatment with steroid injections. In case of uncertainty a pregnancy test is done. Women of childbearing potential not using contraception.
4. Individuals with confirmed or suspected cognitive failure caused by acute or chronical conditions, such as neuro psychiatric illness (eg dementia, retardation etc), patients under intensive care with lowered conciousness.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified