NCT00509392

Brief Summary

The objective of this post-market study is to compare the post-procedure recovery between two types of minimally invasive catheter treatments for venous disease in the Great Saphenous Vein.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 31, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
9.5 years until next milestone

Results Posted

Study results publicly available

July 12, 2017

Completed
Last Updated

July 12, 2017

Status Verified

June 1, 2017

Enrollment Period

10 months

First QC Date

July 27, 2007

Results QC Date

March 22, 2012

Last Update Submit

June 13, 2017

Conditions

Venous Reflux

Keywords

Varicose veins, venous reflux, GSV disease

Outcome Measures

Primary Outcomes (13)

  • Pain

    Pain 0-10 scale (10 most severe)

    48 Hour

  • Pain

    Pain 0-10 scale (10 most severe)

    1 Week

  • Pain

    Pain 0-10 scale (10 most severe)

    2 Weeks

  • Pain

    Pain 0-10 scale (10 most severe)

    1 Month

  • Tenderness

    Tenderness 0-10 scale (10 most severe)

    48 Hour

  • Tenderness

    Tenderness 0-10 scale (10 most severe)

    1 Week

  • Tenderness

    Tenderness 0-10 scale (10 most severe)

    2 Weeks

  • Tenderness

    Tenderness 0-10 scale (10 most severe)

    1 Month

  • Ecchymosis

    0-5 scale (5 most severe) 0: None 1. \<25% 2. 25-50% 3. 50-75% 4. 75-100% 5. Above or below treated (tx) segment

    48 Hours post treatment (no baseline)

  • Ecchymosis

    0-5 scale (5 most severe) 0: None 1. \<25% 2. 25-50% 3. 50-75% 4. 75-100% 5. Above or below tx segment

    1 Week post treatment (no baseline)

  • Ecchymosis

    0-5 scale (5 most severe) 0: None 1. \<25% 2. 25-50% 3. 50-75% 4. 75-100% 5. Above or below tx segment

    2 Weeks post treatment (no baseline)

  • Ecchymosis

    0-5 scale (5 most severe) 0: None 1. \<25% 2. 25-50% 3. 50-75% 4. 75-100% 5. Above or below tx segment

    1 Month post treatment (no baseline)

  • Complications

    Sequelae at any follow-up

    1 month

Secondary Outcomes (8)

  • VCSS

    48 Hours

  • VCSS

    1 Week

  • VCSS

    2 Weeks

  • VCSS

    1 Month

  • Change in CIVIQ QOL

    48 Hours

  • +3 more secondary outcomes

Study Arms (2)

Seg. RF Ablation & ClosureFAST catheter

ACTIVE COMPARATOR

Seg. RF Ablation \& ClosureFAST catheter

Device: Seg. RF Ablation & ClosureFAST catheter

Endovenous Laser

ACTIVE COMPARATOR

Treatment invention of venous disease with an Endovenous Laser.

Device: Endovenous Laser

Interventions

Seg. RF Ablation & ClosureFAST catheterDEVICE

Seg. RF Ablation \& ClosureFAST catheter

Also known as: VNUS
Seg. RF Ablation & ClosureFAST catheter
Endovenous LaserDEVICE

laser catheter

Also known as: Commercially approved laser catheter systems.
Endovenous Laser

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All subjects must provide written informed consent.
  • Must be a candidate for either treatment with Radiofrequency Ablation (RFA) or endovenous laser.

You may not qualify if:

  • Subjects who require additional treatments in either leg within 30 days before or after the study procedure.
  • Subjects who are participating in another investigational study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health Sciences

Portland, Oregon, 97239, United States

Location

Related Publications (1)

  • Almeida JI, Kaufman J, Gockeritz O, Chopra P, Evans MT, Hoheim DF, Makhoul RG, Richards T, Wenzel C, Raines JK. Radiofrequency endovenous ClosureFAST versus laser ablation for the treatment of great saphenous reflux: a multicenter, single-blinded, randomized study (RECOVERY study). J Vasc Interv Radiol. 2009 Jun;20(6):752-9. doi: 10.1016/j.jvir.2009.03.008. Epub 2009 Apr 22.

    PMID: 19395275RESULT

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Eppie Chang, MS; Director Clinical Research
Organization
VNUS Medical Technologies / Covidien (sponsor)
eppie.chang@covidien.com
408-360-7200

Study Officials

  • Lian Cunningham, MD

    VNUS Medical Technologies, A Covidien Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2007

First Posted

July 31, 2007

Study Start

March 1, 2007

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

July 12, 2017

Results First Posted

July 12, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will share

Locations

US(1)