Pilonidal Cyst/FistulaPILOLAS 1940NCT07269548
Evaluation of the Healing of the Pilonidal Cyst After 1940 nm Laser Treatment
An observational study of Pilonidal Cyst/Fistula, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
The aim of this study is to evaluate the extent to which the reduction of energy absorption that laser 1940 nm allows could improve the outcomes and postoperative results of the treatment of pilonidal cysts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pilonidal Cyst/Fistula
- What is being tested?
- pilonidal cyst laser surgery
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 3 Oct 2025to 30 Jun 2026
- 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: patients treated with laser 1940 nm for a pilonidal cyst.
Who may be able to join
- Patients who did not object to the collection of their data
- Patients who underwent surgery for a pilonidal cyst using 1940 nm laser treatment
Who cannot join
- Patients with a history of pilonidal cyst surgery
- Patients who underwent emergency surgery for an abscess
- Patients already included in another therapeutic study protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinique de la Sauvegarde
Lyon, 69009
Benjamin DARNIS, Dr, 04-37-49-66-77 ext. +33, benjamin.darnis@hotmail.fr
About this study
The aim of this study is to evaluate the extent to which the reduction of energy absorption that laser 1940 nm allows could improve the outcomes and postoperative results of the treatment of pilonidal cysts.
- Conditions
- Pilonidal Cyst/Fistula
- Being tested
- pilonidal cyst laser surgery
- Keywords
- healing, Pilonidal Cyst
- Medical subject headings
- Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pilonidal cyst laser surgeryProcedure or surgery
pilonidal cyst using 1940 nm laser treatment
| Study group | Role | What they receive |
|---|---|---|
| LASER 1940 | Patient who underwent surgery for a pilonidal cyst using 1940 nm laser treatment Receives: Procedure: pilonidal cyst laser surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
HEALING
The main objective is to evaluate the healing rate of the pilonidal sinus one month after treatment with Er-YAG laser 1940 nm. Wound healing at one month, defined by the absence of a dressing, is the main evaluation criterion.
Measured: 1 Month
Secondary outcomes (1)
Recidivism
Recidivism is defined by: - The presence of persistent troubling symptoms 6 months after the surgery: suppuration, recurrent wound dehiscence, lack of healing despite care deemed optimal by the expert, reactivation/recurrence of abscesses. - The presence of a characteristic image on MRI if this examination has been carried out: subcutaneous collection, in hyper T2.
Measured: 6 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start3 Oct 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilonidal Cyst/FistulaStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07269548
- Sponsor's protocol ID
- 2024-06-045-P-ERAMD0619
- Acronym
- PILOLAS 1940
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Healing of the Pilonidal Cyst After 1940 nm Laser Treatment
- ClinicalTrials.gov ID
- NCT07269548
- Acronym / sponsor ID
- PILOLAS 1940 / 2024-06-045-P-ERAMD0619
- Conditions
- Pilonidal Cyst/Fistula
- Keywords
- healing, Pilonidal Cyst
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 3 Oct 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 8 Dec 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 aim of this study is to evaluate the extent to which the reduction of energy absorption that laser 1940 nm allows could improve the outcomes and postoperative results of the treatment of pilonidal cysts.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LASER 1940 | – | Procedure: pilonidal cyst laser surgeryPatient who underwent surgery for a pilonidal cyst using 1940 nm laser treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients treated with laser 1940 nm for a pilonidal cyst.
Key inclusion criteria (2 listed)
- Patients who did not object to the collection of their data
- Patients who underwent surgery for a pilonidal cyst using 1940 nm laser treatment
Key exclusion criteria (3 listed)
- Patients with a history of pilonidal cyst surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pilonidal cyst laser surgerypilonidal cyst using 1940 nm laser treatment | Procedure or surgery | LASER 1940 |
Primary outcome
HEALING
Time frame: 1 Month
The main objective is to evaluate the healing rate of the pilonidal sinus one month after treatment with Er-YAG laser 1940 nm. Wound healing at one month, defined by the absence of a dressing, is the main evaluation criterion.
1 secondary outcome
Recidivism
Time frame: 6 Month
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 8 Dec 2025.
Related trials for Pilonidal Cyst/Fistula
RecruitingObservational study
Myriad™ Augmented Soft Tissue Reconstruction Registry
Abdominal Wound Dehiscence, Necrotizing Soft Tissue Infection
RecruitingObservational study
The Impact of Perianal Disease on Patient's Sex Life
Perianal Crohn Disease, Perianal Fistula
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pilonidal Cyst/Fistula, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site 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 2 inclusion and 3 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 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HEALING (time frame: 1 Month). 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 8 Dec 2025.