Pilonidal SinusLASPRONCT07314632
Prospective Study in Laser Treatment of Pilonidal Cysts
An observational study of Pilonidal Sinus, run by Centre Hospitalier Departemental Vendee at 2 sites in France.
Trial summary
The goal of this observational study is to evaluate the recurrence rate after laser treatment of pilonidal sinus within two years of the procedure in adult patients who require this procedure to treat their pilonidal sinus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pilonidal Sinus
- How many people
- 240 participants
- Where
- 2 sitesFrance
- Study dates
- 19 Mar 2026to 12 Jun 2030
- 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: The study will be conducted in two centers that regularly perform laser treatment for pilonidal cysts. Recruitment will be conducted prospectively upon the patients' arrival at the digestive surgery department.
Who may be able to join
- Patients requiring laser surgery for pilonidal sinus, of any type (including recurrence after radical cure or laser treatment)
- Patient able to understand the protocol and having given written informed consent to participate in the study,
- Patient affiliated to the social security system or entitled to it.
Who cannot join
- Patient participating in another interventional clinical research protocol involving a drug or clinical investigation of a medical device
- Patient already included in a research study
- Patient under guardianship, conservatorship, or deprived of liberty
- Patient under an activated future protection mandate
- Patient under family authorization
- Patient under judicial protection.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Clinique des Cèdres
Cornebarrieu
Francesco MARTINI, PH
- Recruiting
CHD Vendée
La Roche-sur-Yon
Tristan GREILSAMER, PH
About this study
Official title: Prospective Study on the Incidence of Recurrence in Laser Treatment of Pilonidal Cysts
The goal of this observational study is to evaluate the recurrence rate after laser treatment of pilonidal sinus within two years of the procedure in adult patients who require this procedure to treat their pilonidal sinus.
The main question it aims to answer is:
- Is there a clinical recurrence (presence of a fistula in the intergluteal cleft) 2 years after laser treatment of pilonidal sinus? Participants who undergo surgery as part of their regular medical care will answer survey questions about recurrence at 1 and 2 years.
- Conditions
- Pilonidal Sinus
- Keywords
- Pilonidal sinus, laser, risk factors, Recurrence rates
- Medical subject headings
- Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients requiring laser surgery for pilonidal sinus | pilonidal sinus of any type (including recurrence after radical cure or laser treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical recurrence
2-year recurrence rate after laser sinusectomy (presence of openings in the intergluteal cleft)
Measured: 2 years post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start19 Mar 2026
- Primary completion12 Jun 2030 (estimated)
- Study completion12 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilonidal SinusStudies 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
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tristan GREILSAMER, PH, Principal investigator, Centre Hospitalier Departemental Vendée
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314632
- Sponsor's protocol ID
- CH25_0098
- Other IDs
- 2025-A02356-43
- Acronym
- LASPRO
- Status last verified
- Mar 2026
- First submitted
- 18 Dec 2025
- Last updated
- 23 Mar 2026
- 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 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on the Incidence of Recurrence in Laser Treatment of Pilonidal Cysts
- ClinicalTrials.gov ID
- NCT07314632
- Acronym / sponsor ID
- LASPRO / CH25_0098
- Conditions
- Pilonidal Sinus
- Keywords
- Pilonidal sinus, laser, risk factors, Recurrence rates
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- 12 Jun 2030 (estimated)
- Study completion
- 12 Jun 2030 (estimated)
- First posted
- 2 Jan 2026 (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 goal of this observational study is to evaluate the recurrence rate after laser treatment of pilonidal sinus within two years of the procedure in adult patients who require this procedure to treat their pilonidal sinus.
The main question it aims to answer is:
- Is there a clinical recurrence (presence of a fistula in the intergluteal cleft) 2 years after laser treatment of pilonidal sinus? Participants who undergo surgery as part of their regular medical care will answer survey questions about recurrence at 1 and 2 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients requiring laser surgery for pilonidal sinus | – | –pilonidal sinus of any type (including recurrence after radical cure or laser treatment) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted in two centers that regularly perform laser treatment for pilonidal cysts. Recruitment will be conducted prospectively upon the patients' arrival at the digestive surgery department.
Key inclusion criteria (3 listed)
- Patients requiring laser surgery for pilonidal sinus, of any type (including recurrence after radical cure or laser treatment)
- Patient able to understand the protocol and having given written informed consent to participate in the study,
- Patient affiliated to the social security system or entitled to it.
Key exclusion criteria (6 listed)
- Patient participating in another interventional clinical research protocol involving a drug or clinical investigation of a medical device
- Patient already included in a research study
- Patient under guardianship, conservatorship, or deprived of liberty
- Patient under an activated future protection mandate
- Patient under family authorization
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
Clinical recurrence
Time frame: 2 years post-operatively
2-year recurrence rate after laser sinusectomy (presence of openings in the intergluteal cleft)
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 23 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Pilonidal Sinus
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Teach-Back Discharge Education After Pilonidal Sinus Surgery
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ENVELOP: Wound Care Following Pilonidal Sinus Surgery
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Laser Coagulation of Pilonidal Sinus With/Without Intraoperative Ultrasound Control
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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.
Tristan GREILSAMER, PH principal investigator
Centre Hospitalier Departemental Vendée
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pilonidal Sinus, run by Centre Hospitalier Departemental Vendee at 2 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 3 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 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 Agnès DORION (0251446380 ext. +33, agnes.dorion@ght85.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical recurrence (time frame: 2 years post-operatively). 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 23 Mar 2026.