Minimally-Invasive Isolated Limb Perfusion | NCT03376126

Studies
Minimally-Invasive Isolated Limb Perfusion

NCT03376126

Sponsor

Vastra Gotaland Region

Status

Unknown status

Last Update Posted

Jan 26, 2024Actual

Enrollment

10Estimated

Phase

Not provided

Conditions

Isolated Limb Perfusion

Interventions

Minimal-invasive isolated limb perfusion

Countries

Sweden

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

Jan 2024

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 1, 2016Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Dec 8, 2017

First Submission Date that Met QC Criteria

Dec 12, 2017

First Posted Date

Dec 18, 2017Actual

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

Jan 25, 2024

Last Update Posted Date

Jan 26, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Roger Olofsson Bagge, Associate professor, Sahlgrenska University HospitalPrincipal Investigator

Lead Sponsor

Vastra Gotaland RegionOTHER_GOV

Collaborators

Not provided

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 aim is to analyse feasibility of a minimally-invasive isolated limb perfusion.

Detailed Description

Isolated limb perfusion (ILP) and isolated limb infusion (ILI) are treatment options for patients with in-transit metastases of melanoma and locally advanced extremity sarcomas. There are several advantages for each method, but if the well-established effects of ILP could be combined to the minimally invasive approach of ILI, the results could be maximized and adverse events, related to open approach, minimized.

A new method for vascular approach (MI-ILP) will be evaluated in a phase I feasibility study. Percutaneous vascular access of the ipsilateral side will be performed by ultrasound guided technique and connected to an extracorporeal oxygenation system. Perfusion will be conducted in the same way as for open ILP. Outcomes, technical details and complications will be recorded prospectively.

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

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MI-ILP			Other: Minimal-invasive isolated limb perfusion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Minimal-invasive isolated limb perfusion	Other	Minimal-invasive isolated limb perfusion	MI-ILP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Conversion to open surgery	Number of minimal-invasive procedure that will be converted to open surgery (per cent)	1 day

Secondary Outcomes

Measure	Description	Time Frame
Response	Clinical response rate according to WHO criteria.	3 months
Complications	Complications according to Clavien-Dindo	30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The patient scheduled for treatment with isolated hyperthermic perfusion
Age over 18 years.
Signed informed consent

Exclusion Criteria:

Re-perfusion
Lymph node metastases
Severe atherosclerosis

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

Patients scheduled for isolated limb perfusion.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Roger Olofsson Bagge, MD, PhD	Contact	+46 31 3420000		roger.olofsson.bagge@gu.se

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sahlgrenska University Hospital	Recruiting	Gothenburg		413 45	Sweden

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