ClinicalTrials.gg
Status unknownNCT01590329Updated May 2, 2012

Use of Epidermal Expansion System for Epidermal Grafting on Hypopigmented Skin and Surgical Wounds

An interventional study of Momelan Technologies Epidermal Graft Harvesting System in Surgical Wound and Hypo-pigmented Skin, sponsored by Momelan Technologies. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-05-02.

Sponsored by Momelan Technologies · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2012), so the status shown — last known as Recruiting — may be out of date.

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Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 129 studies in Surgical Wound with a site in United States — 17 open to participants now, 21 under way, none of them phase 3. Surgical Wound · United States.

Planned enrollment
90th of 111
12 · median 50
Started
2012
with 6 others
No phase
88 of 129
9 open now
Registered
21st of 129
by date

Among the 129 studies in Surgical Wound with a site in United States, this one is the 90th largest by planned enrollment of the 111 interventional ones that give a count, is one of 7 that started in 2012, is one of 88 with no phase, and was the 21st registered.

Surgical Wound

315 studies on the registry are indexed under Surgical Wound; 57 are open to participants now.

Browse Surgical Wound studies →

Open to participants now

17 of the 129 studies in Surgical Wound with a site in United States are open now. Recruiting first, the newest first:

12 more — sign in →

All 17 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 33 Surgical Wound studies recruiting now, 19 (58%) set no upper age limit and 10 (30%) stop at 75 or younger; 6 take children under 18; 7 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

This case series will assess the use of suction blister epidermal grafts harvested by a novel device on select patients with hypo pigmented skin or surgical skin wounds.

Read the detailed description

This study evaluates a novel micrografting technique to determine how it will influence the repigmentation of selected areas of hypopigmentation, and how it will influence the healing and pigmentation of surgical skin wounds. The Epidermal Expansion System (designed by MoMelan Technologies) will generate an array of small microblisters and transfer the micrografts to a sterile FDA cleared wound dressing for application to the subject's acute wound or prepared recipient site. The sponsor hypothesizes that applying expanded micrografts to target sites will result in rapid healing of acute wounds and in repigmentation of hypopigmented skin as well as and provide improved cosmetic outcomes.

03

Conditions studied

  • Surgical Wound
  • Hypo-pigmented Skin

Browse trials for

Keywords

  • Skin surgery
  • Micrografting
  • Hypo-pigmentation
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

  • Male or female adult subject between 18 and 99 years of age
  • Subject having an area of hypopigmentation or surgical wound considered appropriate by physician to receive epidermal micro grafting
  • Willingness to participate in study by evidence of

Exclusion criteria

Exclusion Criteria:

  • Female subjects self-reported to be breastfeeding, pregnant or planning to become pregnant during the course of the study.
  • Subject showing clinical signs of infection
  • Subjects currently on medications, chemotherapy or cytotoxic agents
  • Subject participation in another interventional study with potential exposure to an drug or device within the past 30 days or planned entry into another investigational study within 90 days after entrance into this study
Terms in these criteria, in plain language(3)

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

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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.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    Micrografting

    Device: Momelan Technologies Epidermal Graft Harvesting System

Interventions

  • DeviceMomelan Technologies Epidermal Graft Harvesting System

    The procurement of the epidermal micro graft involves the use of MoMelan Technologies suction blister system, which consists of a control harvester. The device is applied to the subject's thigh to create blisters. The epidermal micrografts are then harvested and transferred to a commercially available sterile film dressing, placed on the surgical wound or prepared recipient site and the wound is then bandaged.

06

What researchers measure

Primary outcomes

  1. Wound healing/pigmentation

    Time frame: up to 12 weeks

Secondary outcomes

  1. Patient Satisfaction

    Time frame: 6-12 weeks

  2. Physician Satisfaction

    Time frame: 6-12 weeks

  3. Incidence of adverse events

    Time frame: 6-12 weeks

07

Study locations

1 of 1 sites recruiting
  • Laser and Skin Surgery Center of New York
    New York, New York 10016, United States
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2012, a primary completion of Oct 2012 and a completion of Oct 2012. It does not say whether these dates are actual or estimated.

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

Registered
May 1, 2012
First posted
May 2, 2012
Start
Mar 2012
Primary completionEst.
Oct 2012
CompletionEst.
Oct 2012
Last update
May 2, 2012
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 May 2, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01590329
Lead sponsor
Momelan Technologies
Responsible party
Sponsor
First posted
May 2, 2012
Start date
Mar 2012
Primary completion
Oct 2012 (estimated)
Completion
Oct 2012 (estimated)
Last update
May 2, 2012

Study contacts

Robert LaRoche
Contact
robert.laroche@momelan.com
978-376-2879
Roy Geronemus, MD
principal investigator · Laser and Skin Surgery Center of New York

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2012. You cannot join it, but the record below documents what was studied.

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