Comparing of Microcoil Localization and Hook Wire Localiz... | NCT02908646

Studies
Comparing of Microcoil Localization and Hook Wire Localization for Resectable Pulmonary Small Nodules

NCT02908646

Sponsor

Peking University People's Hospital

Status

Unknown status

Last Update Posted

Sep 21, 2016Estimated

Enrollment

72Estimated

Phase

Phase 3

Conditions

Thoracic Surgery

Interventions

microcoil localization
hookwire localization

Countries

China

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

Sep 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016

Primary Completion Date

Jun 2017Estimated

Completion Date

Jul 2017Estimated

First Submitted Date

Sep 17, 2016

First Submission Date that Met QC Criteria

Sep 17, 2016

First Posted Date

Sep 21, 2016Estimated

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

Sep 17, 2016

Last Update Posted Date

Sep 21, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jun Wang, Pro, Peking University People's HospitalPrincipal Investigator

Lead Sponsor

Peking University People's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Both of microcoil localization and hookwire localization have been proved as good preoperative CT(computed tomography)-guided techniques to guide VATS resection for the diagnosis of small peripheral pulmonary nodules technique to guide VATS resection for the diagnosis of small peripheral pulmonary nodules. The objective of this study is to determine if microcoil localization for pulmonary nodules can be safer than hookwire localization

Detailed Description

Both of microcoil localization and hookwire localization have been proved as good preoperative CT-guided techniques to guide VATS resection for the diagnosis of small peripheral pulmonary nodules technique to guide VATS(video assisted thoracoscopic surgery) resection for the diagnosis of small peripheral pulmonary nodules. Compared with the commonly used hook wire, the platinum microcoil can be retained in the patients'body and the configuration of which had an effect in reducing the severity of complications. The fibered microcoil may promote blood coagulation of the surrounding lung tissues, block the needle pathway, and decrease the severity of pneumothorax and bleeding caused by the puncture needle, which has been proven in animal experiments. The objective of this study is to determine if microcoil localization for pulmonary nodules can be safer than hookwire localization

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
microcoil	Experimental	patients who plan for microcoil localization	Procedure: microcoil localization
hookwire	Placebo Comparator	patients who plan for hookwire localization	Procedure: hookwire localization

Interventions

Name	Type	Description	Arm Group Labels	Other Names
microcoil localization	Procedure	CT-guided localization by placing a microcoil into the lung parenchyma	microcoil

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
complications after CT-guided localization	any complication occured after CT-guided localization	1 years

Secondary Outcomes

Measure	Description	Time Frame
major complications after CT-guided localization	major complication refers to complication that need to be interfered before surgery	1 years
success of the intervention of localization	success of the intervention of CT guided localization by microcoil or hookwire

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

solid nodules with a diameter ≤1 cm and distance to visceral pleura ≥0.5 cm, -ground-glass nodules,
part-solid ground-glass nodules, with a solid portion ≤1 cm and distance to the visceral pleura ≥1 cm.
peripheral nodules amenable to thoracoscopic wedge excision of the nodules.

Exclusion Criteria:

Patients combined with pneumothorax.
Patients combined with pleural effusion.
Patients with history of hemoptysis.
Patients with medical condition that the radiologist and surgeon disagree for inclusion.

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xizhao Sui, MD	Contact			eastlifer@sina.com
Hui Zhao, MD	Contact			zhaohui@pukph.edu.cn

Overall Officials

Name	Affiliation	Role
Hui Zhao, MD	Department of Thoracic Surgery, Center for Mini-invasive Thoracic Surgery, People's Hospital, Peking University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking university people's hospital	Recruiting	Beijing			China

IPD Sharing Statement Module

Plan to Share IPD

Description

no plan to make individual participant data (IPD) available

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided