Complications of Ethanol-amine Oleate Intralesional Sclerotherapy

• Sponsor: Suez Canal University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04930952
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Actual Duration (Months): 24.1
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The aim of this study is to clarify complications of Ethanolamine Oleate intralesional injections of maxillofacial venous formations in pediatric patients

Condition or Disease	Intervention/Treatment	Phase
Venous Malformation	Drug: Ethanol-amine Oleate Sclerotherapy Injection

Detailed Description

Maxillofacial Venous malformations cause many functional and esthetic complications in children, intralesional sclerotherapy is the best choice of treatment; and Ethanol-amine Oleate has been the most commonly used sclerosing agent.

The aim of this study is to clarify complications of Ethanolamine Oleate intralesional injections of maxillofacial venous formations

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 15 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: Complications of Ethanol-amine Oleate Intralesional Sclerotherapy Injections of Maxillofacial Venous Malformations in Pediatric Patients
• Actual Study Start Date: Feb 28, 2019
• Actual Primary Completion Date: Feb 28, 2021
• Actual Study Completion Date: Mar 3, 2021

Outcome Measures

Primary Outcome Measures

1. Clinical Response [12 months]

   Complete Response - Marked Improvement - Moderate Improvement - No Response

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 12 Years
• Sexes Eligible for Study: All

Inclusion Criteria: maxillofacial venous malformation

-

Exclusion Criteria:

1. Patients with lung, liver, or kidney diseases

2. Patients with Klippel-Trenaunay syndrome

3. Patients mental or physical disabilities

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Suez Canal University	Ismailia		Egypt

Sponsors and Collaborators

• Suez Canal University

Investigators

• Principal Investigator: Sarah Arafat, MSc, Assistant Lecturer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sarah Arafat, Assistant Lecturer, Suez Canal University
• ClinicalTrials.gov Identifier: NCT04930952
• Other Study ID Numbers: 157-2018
• First Posted: Jun 18, 2021
• Last Update Posted: Jun 18, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sarah Arafat, Assistant Lecturer, Suez Canal University: Maxillofacial; Pediatric; Venous Malformations; Ethanol-amine Oleate
• Additional relevant MeSH terms: Congenital Abnormalities; Ethanol

Study Results

No Results Posted as of Jun 18, 2021