Percutaneous Gelled Alcohol Sclerotherapy for Aggressive... | NCT06607731

Studies
Percutaneous Gelled Alcohol Sclerotherapy for Aggressive Angiomas: Evaluation of Feasibility, Safety, and Efficacy

NCT06607731

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Status

Recruiting

Last Update Posted

Oct 8, 2024Actual

Enrollment

11Estimated

Phase

Not provided

Conditions

Bone Angioma

Interventions

Collecting data from medical records

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 25, 2024Actual

Primary Completion Date

Dec 2024Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

Jul 26, 2024

First Submission Date that Met QC Criteria

Sep 19, 2024

First Posted Date

Sep 23, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 7, 2024

Last Update Posted Date

Oct 8, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators aimed to evaluate efficacy and safety of a non-surgical protocol treatment combining transarterial embolization and percutaneous radiopaque gelled ethanol (RGE) sclerotherapy in a first procedure, then followed by vertebroplasty in a second procedure, to treat aggressive vertebral hemangioma patients in tertiary hospital. Exclusion criteria were age <18-years old and any association with neurological deficit.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

11Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study population		Patients who have undergone percutaneous gel ethanol sclerosis for aggressive bone angioma at Saint-Etienne University Hospital.	Other: Collecting data from medical records

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Collecting data from medical records	Other	Data collected: clinical data (particularly pain), biological data, imaging.	Study population

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of complications identified in data collection	Number of complications identified in data collection	Day 1

Secondary Outcomes

Measure	Description	Time Frame
Number of lesion identified in data collection	Number of lesion identified in data collection	Day 1

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Every patients treated by gelled alcohol sclerotherapy for aggressive angiomas, in the University Hospital of Saint-Etienne.

Exclusion Criteria:

Patients no treated by gelled alcohol sclerotherapy.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients who underwent percutaneous gel ethanol sclerosis for aggressive bone angioma at Saint-Étienne University Hospital will be included.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sylvain GRANGE, MD	Contact	(0)477829066	+33	sylvain.grange@chu-st-étienne.fr

Overall Officials

Name	Affiliation	Role
Sylvain GRANGE, MD	Centre Hospitalier Universitaire de Saint Etienne	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Saint-Etienne	Recruiting	Saint-Priest-en-Jarez		42270	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided