Spinal StenosisESCAPENCT06950853
ESCAPE : Evaluation of Spinal Conservation by Endoscopic Procedures to Avoid Fusion
An observational study of Spinal Stenosis and Spondylolisthesis, run by University Hospital, Bordeaux at 13 sites in France.
Trial summary
The recent development and expansion of endoscopic surgery has made it possible to offer an alternative to this therapeutic escalation. This method allows decompression procedures to be performed using optimized and minimally destructive surgical approaches, which contributes to preserving the physiological function… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Stenosis, Spondylolisthesis
- How many people
- 375 participants
- Where
- 13 sitesFrance
- Study dates
- 1 Feb 2024to 13 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: lumbar spine surgery patients with pathologies eligible for arthrodesis surgery
Who may be able to join
- Patient ≥ 18 years old
- Patient consulting for a medical reason involving a spinal pathology in the investigating center :
- Syndrome adjacent to an old lumbar arthrodesis defined on preoperative radiographs by an antero-posterior translation > 3 mm, segmental kyphosis > 10° or a disc height reduced by more than 50%, or on preoperative MRI by central stenosis of grade C or D of the Schizas classification or a herniated disc Grade 1 or 2 degenerative spondylolisthesis, i.e. with slippage less than 50% of the depth of the underlying vertebral body.
- Lumbar stenosis complicating lumbar scoliosis defined by a deformation with rotation of the vertebral bodies on a frontal radiograph (absence of centering of the spinous process between the two pedicles of the vertebra concerned) and a Cobb angle greater than 20° or a rotational dislocation .
- Indication for spinal surgery by endoscopy
Who cannot join
- Patient under guardianship or curatorship,
- Persons deprived of liberty by judicial or administrative decision,
- Persons undergoing psychiatric treatment under duress requiring the consent of the legal representative
- Persons unable to express their consent,
- Persons under legal protection,
- Patient not affiliated to a social protection scheme.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
France13 sites, 13 recruiting
- Recruiting
Hôpital Pellegrin, Centre Hospitalier Universitaire de Bordeaux
Bordeaux, 33000
Benjamin BOUYER, PROF, +335 56 79 87 18, b.bouyer@chu-bordeaux.fr
- Recruiting
Clinique du dos de Bordeaux -Terrefort
Bruges, 33520
Nicolas PELLET
- Not yet recruiting
CHU Lille
Lille, 59037
Henri-Arthur LEROY
- Not yet recruiting
Centre orthopédique SANTY
Lyon, 69008
Henri D'ASTORG
- Not yet recruiting
Centre orthopédique SANTY
Lyon, 69008
Xavier CASTEL
- Recruiting
Hôpital CLAIRVAL
Marseille, 13009
François-Xavier FERRACCI
- Recruiting
CH de Narbonne
Narbonne, 11108
Stanislas MAROUBY
- Not yet recruiting
Centre hospitalier Privé Sainte Marie
Osny, 95520
Robin ARVIEU
- Recruiting
Clinique du sport
Pessac, 33600
Amélie LEGLISE
- Recruiting
Institut locomoteur de l'Ouest-Rachi
Saint-Grégoire, 35760
Jonanthan LEBHAR
- Recruiting
Cabinet Orthosud Montpellier-Clinique Saint Jean
Saint-Jean-de-Védas, 34430
Guillaume LONJON
- Recruiting
Cabinet Orthosud Montpellier-Clinique Saint Jean
Saint-Jean-de-Védas, 34430
Matthieu VASSAL
- Recruiting
Cabinet Orthosud Montpellier-Clinique Saint Jean
Saint-Jean-de-Védas, 34430
Alexandre DHENIN
About this study
The recent development and expansion of endoscopic surgery has made it possible to offer an alternative to this therapeutic escalation. This method allows decompression procedures to be performed using optimized and minimally destructive surgical approaches, which contributes to preserving the physiological function of the lumbar spine and in particular its stability.
The main hypothesis of the research is that the use of endoscopic techniques for decompression of the lumbar spine allows a reduction in the indication for lumbar arthrodesis.
- Conditions
- Spinal Stenosis, Spondylolisthesis
- Keywords
- spine, care, surgery
- Medical subject headings
- Spinal Stenosis, Spondylolisthesis
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical reintervention
rate of surgical reinterventions within the year for arthrodesis of the operated segment.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start1 Feb 2024
- Primary completion1 Aug 2027 (estimated)
- Study completion13 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin BOUYER, PROF, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950853
- Sponsor's protocol ID
- CHUBX 2023/60
- Acronym
- ESCAPE
- Status last verified
- Apr 2025
- First submitted
- 22 Apr 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ESCAPE : Evaluation of Spinal Conservation by Endoscopic Procedures to Avoid Fusion
- ClinicalTrials.gov ID
- NCT06950853
- Acronym / sponsor ID
- ESCAPE / CHUBX 2023/60
- Conditions
- Spinal Stenosis, Spondylolisthesis
- Keywords
- spine, care, surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 375 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 13 Aug 2028 (estimated)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The recent development and expansion of endoscopic surgery has made it possible to offer an alternative to this therapeutic escalation. This method allows decompression procedures to be performed using optimized and minimally destructive surgical approaches, which contributes to preserving the physiological function of the lumbar spine and in particular its stability.
The main hypothesis of the research is that the use of endoscopic techniques for decompression of the lumbar spine allows a reduction in the indication for lumbar arthrodesis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- lumbar spine surgery patients with pathologies eligible for arthrodesis surgery
Key inclusion criteria (5 listed)
- Patient ≥ 18 years old
- Patient consulting for a medical reason involving a spinal pathology in the investigating center :
- Syndrome adjacent to an old lumbar arthrodesis defined on preoperative radiographs by an antero-posterior translation > 3 mm, segmental kyphosis > 10° or a disc height reduced by more than 50%, or on preoperative MRI by central stenosis of grade C or D of the Schizas classification or a herniated disc Grade 1 or 2 degenerative spondylolisthesis, i.e. with slippage less than 50% of the depth of the underlying vertebral body.
- Lumbar stenosis complicating lumbar scoliosis defined by a deformation with rotation of the vertebral bodies on a frontal radiograph (absence of centering of the spinous process between the two pedicles of the vertebra concerned) and a Cobb angle greater than 20° or a rotational dislocation .
- Indication for spinal surgery by endoscopy
Key exclusion criteria (6 listed)
- Patient under guardianship or curatorship,
- Persons deprived of liberty by judicial or administrative decision,
- Persons undergoing psychiatric treatment under duress requiring the consent of the legal representative
- Persons unable to express their consent,
- Persons under legal protection,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Surgical reintervention
Time frame: one year
rate of surgical reinterventions within the year for arthrodesis of the operated segment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benjamin BOUYER, PROF principal investigator
University Hospital, Bordeaux
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Stenosis and Spondylolisthesis, run by University Hospital, Bordeaux at 13 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin BOUYER, PROF (+335 56 79 87 18, b.bouyer@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical reintervention (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025; AzTrials last refreshed its copy on 31 Oct 2026.