ClinicalTrials.gg
CompletedNCT04297579NAEVUSUpdated Jun 5, 2020

Congenital Naevi of Lower Limb in the Child

An observational study in Congenital Melanocytar Nevi in the Lower Limb, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2020-06-05.

Sponsored by University Hospital, Montpellier · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
176
Ages
Up to 18 Years
Sex
All
01

Study summary

Depending on its dimensions, it is difficult to predict if a congenital nevi of the lower limb can be surgically removed by a unique simple procedure or by a complex procedure (expander, skin graft etc..), with a good result.

This study retrospectively reviewed the practice of our team of surgeons depending on the size of the naevus to reveal a dimension threshold that can be used in the future to help to choose between a simple or a complex procedure.

Read the detailed description

Retrospective study using medical file data only. No intervention nor phone call etc.. to the patients or their parents.

02

Conditions studied

  • Congenital Melanocytar Nevi in the Lower Limb

Browse trials for

Keywords

  • congenital nevi
  • naevus
  • Congenital skin neoplasm
  • Reconstructive surgical procedures
03

In context

Nevus

47 studies on the registry are indexed under Nevus; 9 are open to participants now.

This study's enrollment of 176 is above the median of 145 across 28 observational studies indexed under Nevus.

Browse Nevus studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 224 are open to participants now.

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

04

Who can participate

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

Study population

Children that had congenital nevi surgery removal, in the lower limb.

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

  • Child + congenital nevi in the lower limb + had removal surgery

Exclusion criteria

Exclusion criteria:

  • More than one congenital nevi in the lower limb.
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
176 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Nevi Estimated Size

    Nevi Estimated Size (centimeters)

    Time frame: within three weeks after surgery

Secondary outcomes

  1. post-operative complications depending on the initial size of the naevus

    post-operative complications depending on the initial size of the naevus : percentage of complication rate

    Time frame: assessed within 6 months after surgery

07

Study locations

1 site
  • Uhmontpellier
    Montpellier, 34295, France
08

References and documents

Individual participant data

Plan to share: Undecided — NC

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04297579
Responsible party
Sponsor
First posted
Mar 5, 2020
Start date
Jan 1, 1984
Primary completion
Apr 1, 2020
Completion
May 1, 2020
Last update
Jun 5, 2020

Study contacts

Guillaume CAPTIER, MD.PhD
study director · University Hospital, Montpellier

Oversight

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

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion