Evaluation of Faisability, Safety and Effectiveness and of Discogel in Patients With Aneurysmal and Simple Bone Cysts

Bone Cysts Clinical Trial

Official title:

Evaluation of Faisability, Safety and Effectiveness and of Discogel in Patients With Aneurysmal and Simple Bone Cysts

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05880628
• Other study ID #: IRBN552022/CHUSTE
• Status: Recruiting
• Start date: April 14, 2022
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Sylvain Grange, MD
• Phone: (0)477829066
• Email: Sylvain.Grange[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

There is no consensus in the scientific literature for the treatment of aneurysmal and simple bone cysts. Some scientific articles with utilisation of sclerosis agents for the treatment of aneurysmal bone cysts: Ethibloc no longer marketed, pure Ethanol, Aetoxisclerol.

Description:

The aim of this work is therefore the evaluation of Discogel® in the treatment of Discogel®, which appears to be a safe and efficacity of method.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patient with aneurysmal or simple bone cyst who benefit a sclerotherapy by Discogel

Exclusion Criteria:

• Refusal

Related Conditions & MeSH terms

• Bone Cysts
• Cysts

Intervention

Other:
• datas of medical record.
Analysis datas of medical record: Feasibility of the technique Safety of the technique Efficacity (sclerose of the lesion)

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the technique	Collect from medical records the number of procedures that were completed and performed as theoretically intended.	Year: 2
Secondary	Safety of the technique by number of adverse event	collect in the medical record	Year: 2
Secondary	Number of discogel® injections by sclerose of the lesion	Efficacity of the technique	Year: 2