ClinicalTrials.gg
RecruitingNCT07314632LASPROUpdated Mar 23, 2026

Prospective Study in Laser Treatment of Pilonidal Cysts

An observational study in Pilonidal Sinus, sponsored by Centre Hospitalier Departemental Vendee. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-23.

Sponsored by Centre Hospitalier Departemental Vendee · Observational

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
240
Ages
18 Years and older
Sex
All
01

Study 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.

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.
02

Conditions studied

  • Pilonidal Sinus

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Keywords

  • Pilonidal sinus
  • laser
  • risk factors
  • Recurrence rates
03

In context

Pilonidal Sinus

109 studies on the registry are indexed under Pilonidal Sinus; 32 are open to participants now.

This study's planned enrollment of 240 is above the median of 145 across 37 observational studies indexed under Pilonidal Sinus.

Browse Pilonidal Sinus studies →

Lead sponsor

Centre Hospitalier Departemental Vendee is the lead sponsor of 83 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 to participate in the study,
  • Patient affiliated to the social security system or entitled to it.

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
240 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients requiring laser surgery for pilonidal sinus

    pilonidal sinus of any type (including recurrence after radical cure or laser treatment)

06

What researchers measure

Primary outcomes

  1. Clinical recurrence

    2-year recurrence rate after laser sinusectomy (presence of openings in the intergluteal cleft)

    Time frame: 2 years post-operatively

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2026 (actual). Primary completion is estimated for Jun 2030, 50 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 18, 2025
First posted
Jan 2, 2026
StartActual
Mar 19, 2026
Primary completionEst.
Jun 12, 2030
CompletionEst.
Jun 12, 2030
Last update
Mar 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07314632
Lead sponsor
Centre Hospitalier Departemental Vendee
Responsible party
Sponsor
First posted
Jan 2, 2026
Start date
Mar 19, 2026
Primary completion
Jun 12, 2030 (estimated)
Completion
Jun 12, 2030 (estimated)
Last update
Mar 23, 2026

Study contacts

Agnès DORION
Contact
agnes.dorion@ght85.fr
0251446380 ext. +33
Tristan GREILSAMER, PH
principal investigator · Centre Hospitalier Departemental Vendée

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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