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Trial Outcomes & Findings for Real-World Outcomes Study on Subjects Treated With Radiofrequency Ablation (NCT NCT04873817)

NCT ID: NCT04873817

Last Updated: 2024-11-20

Results Overview

The pain NRS consists of 1 question that will be asked by interviewing the subjects. Patients will be asked to rate, from 0 (no pain) to 10 (worst imaginable pain), their average pain over the past 24 hours specific to the area(s) of chronic pain being treated. A higher score indicates greater pain intensity. The presented outcome denotes the mean relative change in NRS score, which was defined as (Baseline score - 3-month follow-up visit score)/ Baseline score\*100%. Higher scores indicate greater relative pain relief. Minimum value is 0% and maximum value is 100%.

Recruitment status

COMPLETED

Target enrollment

184 participants

Primary outcome timeframe

Baseline to 3 months

Results posted on

2024-11-20

Participant Flow

The study has enrolled 184 subjects at 11 clinical sites in EU and the US. The total duration of the study is expected to be 20 months, including enrollment, data collection from all subjects, and study closeout.

Participant milestones

Participant milestones
Measure
IonicRF Generator and Compatible Accessories
IonicRF Radiofrequency Generator, along with any country-specific market-released accessory (i.e. electrode, cannula, grounding pad, and adaptor cable) compatible with the IonicRF Generator will be used.
Overall Study
STARTED
184
Overall Study
COMPLETED
165
Overall Study
NOT COMPLETED
19

Reasons for withdrawal

Reasons for withdrawal
Measure
IonicRF Generator and Compatible Accessories
IonicRF Radiofrequency Generator, along with any country-specific market-released accessory (i.e. electrode, cannula, grounding pad, and adaptor cable) compatible with the IonicRF Generator will be used.
Overall Study
Subject and/or Family Request Withdrew Consent
3
Overall Study
Lost to Follow-up
4
Overall Study
Unsuccessful RFA Procedure
1
Overall Study
Additional Chronic Pain Treatment for The Same Anatomical Region
8
Overall Study
Other Reasons
3

Baseline Characteristics

Real-World Outcomes Study on Subjects Treated With Radiofrequency Ablation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
IonicRF Generator and Compatible Accessories
n=179 Participants
IonicRF Radiofrequency Generator, along with any country-specific market-released accessory (i.e. electrode, cannula, grounding pad, and adaptor cable) compatible with the IonicRF Generator will be used.
Age, Continuous
59.2 years
STANDARD_DEVIATION 13.2 • n=5 Participants
Sex: Female, Male
Female
127 Participants
n=5 Participants
Sex: Female, Male
Male
52 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
18 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
96 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
65 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=5 Participants
Race (NIH/OMB)
Asian
1 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
8 Participants
n=5 Participants
Race (NIH/OMB)
White
120 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
49 Participants
n=5 Participants
Duration of Chronic Pain (Years)
9.0 years
STANDARD_DEVIATION 8.3 • n=5 Participants
Number of diagnostic blocks provided to participants prior to therapy implementation
1
47 Participants
n=5 Participants
Number of diagnostic blocks provided to participants prior to therapy implementation
2
73 Participants
n=5 Participants
Number of diagnostic blocks provided to participants prior to therapy implementation
0
59 Participants
n=5 Participants
Pain Relief after the first diagnostic block
71.9 units on a scale
STANDARD_DEVIATION 18.1 • n=5 Participants
Pain Relief after second diagnostic block
74.4 units on a scale
STANDARD_DEVIATION 17.1 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 3 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The pain NRS consists of 1 question that will be asked by interviewing the subjects. Patients will be asked to rate, from 0 (no pain) to 10 (worst imaginable pain), their average pain over the past 24 hours specific to the area(s) of chronic pain being treated. A higher score indicates greater pain intensity. The presented outcome denotes the mean relative change in NRS score, which was defined as (Baseline score - 3-month follow-up visit score)/ Baseline score\*100%. Higher scores indicate greater relative pain relief. Minimum value is 0% and maximum value is 100%.

Outcome measures

Outcome measures
Measure
IonicRF Generator and Compatible Accessories
n=162 Participants
IonicRF Radiofrequency Generator, along with any country-specific market-released accessory (i.e. electrode, cannula, grounding pad, and adaptor cable) compatible with the IonicRF Generator will be used.
Primary Effectiveness Endpoint: Relative Change in Numeric Rating Scale (NRS) From Baseline to 3 Months Follow-up Visit
34.4 score on a scale
Standard Deviation 35.7

PRIMARY outcome

Timeframe: At 3 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Number of participants with Device- and Procedure-related Serious Adverse Events.

Outcome measures

Outcome measures
Measure
IonicRF Generator and Compatible Accessories
n=162 Participants
IonicRF Radiofrequency Generator, along with any country-specific market-released accessory (i.e. electrode, cannula, grounding pad, and adaptor cable) compatible with the IonicRF Generator will be used.
Primary Safety Endpoint: Incidence of Device- and Procedure-related Serious Adverse Events
0 Participants

Adverse Events

IonicRF Generator and Compatible Accessories

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

Devyani Nanduri, Sr. Director, Clinical and Regulatory Affairs

Abbott

Phone: +16698329450

Results disclosure agreements

  • Principal investigator is a sponsor employee * The PI may publish provided that he/she provides the Sponsor with a draft of any Study-related publication, presentation or other disclosure ("Publication") at least sixty (60) calendar days prior to any submission for Sponsor's review * The PI may not publish the data and results separately from its site until publication of the results of the multi-center study or 18 months after study closure, whichever is sooner.
  • Publication restrictions are in place

Restriction type: OTHER