Trial Outcomes & Findings for Percutaneous HydroDiscectomy Compared to TESI for Radiculopathy (NCT NCT02414698)

Results Overview

Pain improvement in all patients in HydroD arm with at least 50% reduction in leg and back pain.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

4 participants

Primary outcome timeframe

6 months

Results posted on

2020-03-02

Participant Flow

Participant milestones

Participant milestones
Measure	Percutaneous Hydrodiscectomy Percutaneous Hydrodiscectomy with the SpineJet Hydrodiscectomy System Percutaneous Hydrodiscectomy: The HydroD uses a thin supersonic stream of water to cut, ablation, remove disc material percutaneously via a skin puncture.	TESI Transforaminal Epidural Steroid Injections TESI: Transforaminal epidural steroid injections given in the lumbar spine.
Overall Study STARTED	3	1
Overall Study COMPLETED	3	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Percutaneous Hydrodiscectomy n=3 Participants Percutaneous Hydrodiscectomy with the SpineJet Hydrodiscectomy System Percutaneous Hydrodiscectomy: The HydroD uses a thin supersonic stream of water to cut, ablation, remove disc material percutaneously via a skin puncture.	TESI n=1 Participants Transforaminal Epidural Steroid Injections TESI: Transforaminal epidural steroid injections given in the lumbar spine.	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=3 Participants	0 Participants n=1 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=3 Participants	1 Participants n=1 Participants	4 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=3 Participants	0 Participants n=1 Participants	0 Participants n=4 Participants
Age, Continuous	45 years STANDARD_DEVIATION 5 • n=3 Participants	45 years STANDARD_DEVIATION 0 • n=1 Participants	45 years STANDARD_DEVIATION 5 • n=4 Participants
Sex: Female, Male Female	2 Participants n=3 Participants	1 Participants n=1 Participants	3 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=3 Participants	0 Participants n=1 Participants	1 Participants n=4 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	3 Participants n=3 Participants	1 Participants n=1 Participants	4 Participants n=4 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Data were not collected.

Pain improvement in all patients in HydroD arm with at least 50% reduction in leg and back pain.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Population: Data were not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Population: Data were not collected

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Patient self assessment of the Global Improvement Impression of Change (PGIC)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Procedure and device related adverse events

Outcome measures

Outcome data not reported

Adverse Events

Percutaneous Hydrodiscectomy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

TESI

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

Sayed E Wahezi, MD

Montefiore Medical Center

Phone: 7189207246

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place