- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07269548
Evaluation of the Healing of the Pilonidal Cyst After 1940 nm Laser Treatment (PILOLAS 1940)
November 25, 2025 updated by: GCS Ramsay Santé pour l'Enseignement et la Recherche
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 Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lyon, France, 69009
- Recruiting
- Clinique de la Sauvegarde
-
Contact:
- Benjamin DARNIS, Dr
- Phone Number: +33 04-37-49-66-77
- Email: benjamin.darnis@hotmail.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
patients treated with laser 1940 nm for a pilonidal cyst.
Description
Inclusion Criteria:
- Patients who did not object to the collection of their data
- Patients who underwent surgery for a pilonidal cyst using 1940 nm laser treatment
Exclusion Criteria:
Patients with a history of pilonidal cyst surgery
- Patients who underwent emergency surgery for an abscess
- Patients already included in another therapeutic study protocol
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
LASER 1940
Patient who underwent surgery for a pilonidal cyst using 1940 nm laser treatment
|
pilonidal cyst using 1940 nm laser treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 Month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recidivism
Time Frame: 6 Month
|
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.
|
6 Month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 3, 2025
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Study Registration Dates
First Submitted
November 25, 2025
First Submitted That Met QC Criteria
November 25, 2025
First Posted (Actual)
December 8, 2025
Study Record Updates
Last Update Posted (Actual)
December 8, 2025
Last Update Submitted That Met QC Criteria
November 25, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-06-045-P-ERAMD0619
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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