NCT02367378

Brief Summary

The purpose of this study is to collect information on the effect of minimally invasive spine tumor decompression on treated patients. This treatment option is less invasive that the standard surgical decompression and is expected to result in better wound healing, decreased tissue trauma, and decreased pain after surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2015

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

February 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 20, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2016

Completed
Last Updated

June 20, 2017

Status Verified

June 1, 2017

Enrollment Period

1.4 years

First QC Date

February 13, 2015

Last Update Submit

June 19, 2017

Conditions

Spine Metastases

Keywords

Minimally invasive surgery

Outcome Measures

Primary Outcomes (1)

  • Survival time

    Survival time in days

    up to 2 years

Secondary Outcomes (2)

  • Ambulation Index

    up to 2 years

  • Cobb Angle

    up to 2 years

Study Arms (2)

MIS

Those who received minimally invasive surgical procedures

Control

Those who received treatments which include surgical resection, chemotherapy, and radiotherapy.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chart review of patients having undergone minimally invasive surgery of spine metastases, 18 years and older.

You may qualify if:

  • undergone minimally invasive surgery
  • over 18 years of age

You may not qualify if:

  • unable to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Study Officials

  • Arthur Jenkins, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2015

First Posted

February 20, 2015

Study Start

February 1, 2015

Primary Completion

June 13, 2016

Study Completion

June 13, 2016

Last Updated

June 20, 2017

Record last verified: 2017-06

Locations

US(1)