NCT05880628

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

April 14, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 30, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

2.6 years

First QC Date

May 19, 2023

Last Update Submit

March 8, 2024

Conditions

Bone Cysts

Keywords

Bone CystsAneurysmal Bone Cystssimple Bone CystsDiscogelEffectivenessSafety

Outcome Measures

Primary Outcomes (1)

  • Feasibility of the technique

    Collect from medical records the number of procedures that were completed and performed as theoretically intended.

    Year: 2

Secondary Outcomes (2)

  • Safety of the technique by number of adverse event

    Year: 2

  • Number of discogel® injections by sclerose of the lesion

    Year: 2

Study Arms (1)

Any patient with aneurysmal or simple bone cyst who benefit a sclerotherapy by Discogel®

Any patient with aneurysmal or simple bone cyst who benefit a sclerotherapy by Discogel® will be included. Analysis datas of medical record.

Other: datas of medical record.

Interventions

datas of medical record.OTHER

Analysis datas of medical record: * Feasibility of the technique * Safety of the technique * Efficacity (sclerose of the lesion)

Any patient with aneurysmal or simple bone cyst who benefit a sclerotherapy by Discogel®

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with aneurysmal or simple bone cyst who benefit a sclerotherapy by Discogel will be included.

You may qualify if:

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

You may not qualify if:

  • Refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, France

RECRUITING

MeSH Terms

Conditions

Bone CystsBone Cysts, Aneurysmal

Condition Hierarchy (Ancestors)

CystsNeoplasmsBone DiseasesMusculoskeletal Diseases

Study Officials

  • Sylvain Grange, MD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sylvain Grange, MD

CONTACT

(0)477829066Sylvain.Grange@chu-st-etienne.fr

Valentin Gineys, resident

CONTACT

(0)477829066Sylvain.Grange@chu-st-etienne.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2023

First Posted

May 30, 2023

Study Start

April 14, 2022

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

March 12, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)