Trial Outcomes & Findings for A Prospective Randomized Postmarket Clinical Study of the TRANSITION Stabilization System (NCT NCT02184520)

NCT ID: NCT02184520

Last Updated: 2021-03-15

Results Overview

The study was terminated prior to primary and secondary endpoint data collection, therefore no study data is reported.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

24 months

Results posted on

2021-03-15

Participant Flow

The study was terminated prior to primary and secondary endpoint data collection, therefore no study data is reported.

Participant milestones

Participant milestones
Measure
TRANSITION
Stabilization System TRANSITION
REVERE
Stabilization System REVERE
Overall Study
STARTED
0
0
Overall Study
COMPLETED
0
0
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Prospective Randomized Postmarket Clinical Study of the TRANSITION Stabilization System

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 24 months

Population: The study was terminated prior to primary and secondary endpoint data collection, therefore no study data is reported.

The study was terminated prior to primary and secondary endpoint data collection, therefore no study data is reported.

Outcome measures

Outcome data not reported

Adverse Events

TRANSITION

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

REVERE

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jacqueline Myer

Globus Medical

Phone: 610-930-1800

Results disclosure agreements

  • Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results.
  • Publication restrictions are in place

Restriction type: OTHER