NCT05513898

Brief Summary

Observational study on the treatment of pilonidal cyst with Holmium laser. Single-centre retrospective study of medical data from patients' medical records

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
231

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 24, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

July 1, 2024

Status Verified

June 1, 2024

Enrollment Period

10 months

First QC Date

June 23, 2022

Last Update Submit

June 28, 2024

Conditions

Pilonidal Cyst

Outcome Measures

Primary Outcomes (1)

  • Healing rate

    explanatory analysis of the healing rate at Month 1

    Month 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients participating in the study were operated on at the centre between AUGUST and NOVEMBER 2020. The study is based solely on a review of the medical records of these patients. No further evaluation is planned.

You may qualify if:

  • Patient aged 18 years or older, who has been informed of the research;
  • Patient with a pilonidal cyst treated with Holmium Laser during a scheduled procedure.

You may not qualify if:

  • Patient under legal protection, guardianship or curatorship;
  • Patient who has indicated his opposition to the use of his data.
  • Patient undergoing emergency surgery for an abscess

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique de la Sauvegarde

Lyon, 69009, France

Location

MeSH Terms

Conditions

Pilonidal Sinus

Condition Hierarchy (Ancestors)

CystsNeoplasms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2022

First Posted

August 24, 2022

Study Start

April 1, 2022

Primary Completion

January 31, 2023

Study Completion

January 31, 2023

Last Updated

July 1, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)