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OpenTrials
Completed

NCT Number: NCT04563793

Postmarket Outcomes Study for Evaluation of the Superion™ Spacer

To compile real-world outcomes of the Superion™ IDS in routine clinical practice.

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Key information

Conditions

Lumbar Spinal Stenosis Bone Diseases Musculoskeletal Diseases Spinal Diseases Spinal Stenosis

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pain Medicine Associates, Fountain Valley, California, United States

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About this study

The purpose of this outcomes study is to compile real-world outcomes for the commercially approved Indirect Decompression Systems (IDS) in routine clinical practice when used according to the applicable Instructions for Use.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Scheduled to receive or previously received a commercially approved Boston Scientific Indirect Decompression Systems, per local Instructions for Use (IFU)
  • Signed a valid, IRB approved informed consent form

Key Exclusion Criteria:

  • Meets any contraindication in BSC Indirect Decompression Systems local IFU

Treatment and study plan

Superion™ IDS

Device

All patients to receive IDS for the treatment of moderate Lumbar Spinal Stenosis symptoms.

Primary outcomes

  1. Low Back Pain Responder Rate

    Time frame: Up to 3 years post-procedure

    Proportion of subjects with an improvement of 20 mm during the last 7 days for low back pain at 6 months, 1 year, 2 years, and 3 years post-procedure compared with Baseline (VAS)

  2. Left Leg Pain Responder Rate

    Time frame: Up to 3 years post-procedure

    Proportion of subjects with an improvement of 20 mm during the last 7 days for left leg pain at 6 months, 1 year, 2 years, and 3 years post-procedure compared with Baseline (VAS)

  3. Right Leg Pain Responder Rate

    Time frame: Up to 3 years post-procedure

    Proportion of subjects with an improvement of 20 mm during last 7 days for left leg pain at 6 months, 1 year, 2 years, and 3 years post-procedure compared with Baseline (VAS)

Other outcomes

  1. Percent Low Back Pain Relief

    Time frame: Up to 3 years post-procedure

    Percent Low Back Pain Relief at 6 months, 1 year, 2 years and 3 years post-procedure compared with Baseline (PPR).

    PPR is a questionnaire assessing how much of the subject's low back pain has been relieved by treatment. Pain relief is expressed as a percentage from 0 - 100%.

  2. Quality of Life (QoL)

    Time frame: Up to 3 years post-procedure

    Percent of change from Baseline index score to the Follow-up timepoints index score using EQ-5D-5L.

    EuroQol Five Dimensions Five Level questionnaire (EQ-5D-5L) is comprised of a descriptive system and a visual analog scale (VAS). The descriptive system measures quality of life along five dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with five levels for each dimension from which subjects are asked to select one. VAS is used to record the subject's self-rated health on a 20cm vertical line with endpoints labeled 'the best health you can imagine' and 'the worst health you can imagine'. To calculate the Index Value, responses are converted into a single score using a specific algorithm. Score ranges from 0.000 (representing death) to 1.000 (representing perfect health). The algorithm is based on public preferences, reflecting how different health states are valued by the general public.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Acronym: PRESS2

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 24, 2020
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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