Tampa Associating Microwave Liver Ablation With Portal Ve... | NCT03739164

Studies
Tampa Associating Microwave Liver Ablation With Portal Vein Ligation for Staged Hepatectomy (TAMLAPS)

NCT03739164

Sponsor

Florida Hospital Tampa Bay Division

Status

Unknown status

Last Update Posted

Nov 13, 2018Actual

Enrollment

10Estimated

Phase

Not provided

Conditions

Liver Cancer
Liver Tumor
Hepatocellular Carcinoma
Hilar Cholangiocarcinoma

Interventions

Not provided

Countries

United States

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

Nov 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 18, 2018Actual

Primary Completion Date

Aug 1, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Nov 9, 2018

First Submission Date that Met QC Criteria

Nov 9, 2018

First Posted Date

Nov 13, 2018Actual

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

Nov 9, 2018

Last Update Posted Date

Nov 13, 2018Actual

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

This is a study following the outcomes and survival of patients undergoing the TAMLAPS hepatectomy at Florida Hospital Tampa by Dr. Iswanto Sucandy

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

Yes

Target Follow-Up Duration

100 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

10Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Growth of the Future Liver remnant	1. Liver growth determined by measuring the kinetic growth rate obtained from pre-operative and post-op stage one CT evaluations of the FLR volume	2 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Patients scheduled to undergo the TAMLAPS procedure by Dr. Iswanto Sucandy.

Exclusion Criteria:

Subjects with history of noncompliance.
Subjects with physical health, substance abuse, or mental health problems that will limit the subject's ability to meet study requirements

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Adults between the ages of 18 and 80 with indication for hepatectomy of >70% liver volume

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Florida Hospital Tampa		Tampa	Florida	33613	United States

Condition Browse Module

MeSH Terms

ID	Term
D008113	Liver Neoplasms
D006528	Carcinoma, Hepatocellular
D018285	Klatskin Tumor

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided