Sutures in Orbital Implants in Retinoblastoma Patients | NCT04383860

Studies
Sutures in Orbital Implants in Retinoblastoma Patients

NCT04383860

Sponsor

Sun Yat-sen University

Status

Completed

Last Update Posted

Jun 15, 2021Actual

Enrollment

132Actual

Phase

Not Applicable

Conditions

Surgery--Complications
Retinoblastoma Bilateral

Interventions

5-0 suture
4-0 suture

Countries

Not provided

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

Jun 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2015Actual

Primary Completion Date

Dec 31, 2017Actual

Completion Date

Jul 1, 2020Actual

First Submitted Date

May 7, 2020

First Submission Date that Met QC Criteria

May 7, 2020

First Posted Date

May 12, 2020Actual

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

Jun 14, 2021

Last Update Posted Date

Jun 15, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 purpose of this study is to evaluate different sutures for orbital implants in retinoblastoma patients.

Detailed Description

To evaluate the effectiveness and complications of 4-0 and 5-0 sutures for orbital implants in retinoblastoma patients.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

132Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
5-0 suture	Experimental	5-0 suture administration during surgery	Procedure: 5-0 suture
4-0 suture	Active Comparator	4-0 suture administration during surgery	Procedure: 4-0 suture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
5-0 suture	Procedure	5-0 suture administration during surgery	5-0 suture

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of participants with complications	complications, such as orbital implant exposure in the follow-up visit	2 year after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diagnosed as retinoblastoma
enucleation and orbital implantation in the same surgery

Exclusion Criteria:

death during follow-up

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Huijing Ye	Sun Yat-sen University	Principal Investigator

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

Condition Browse Module

MeSH Terms

ID	Term
D012175	Retinoblastoma

Ancestor Terms

ID	Term
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

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Browse Branches

Not provided