GynecomastiaNCT03319862
Post-massive Weight Loss Chest Contouring: Inferior Pedicle Technique in Pseudo-gynecomastia Correction
An observational study of Gynecomastia, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
The massive weight loss leads an important excess of skin on thoracic level giving the aspect of a feminine breast with a relatively important ptose. Several techniques were described in the literature about gynaecomastia , but the post-bariatric pseudo-gynaecomastia was not handled yet enough. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Gynecomastia
- What is being tested?
- Inferior pédicule gynaecomastia
- Type of treatment
- Surgery or procedure
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 14 Nov 2016to 2 Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: every patient hospitalized for gynaecomastia but only whose have a inferior pedicle gynaecomastia are selected for the project.
Who may be able to join
- inferior pedicle gynaecomastia surgery
- Age > 16
Who cannot join
- Age < 16
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
The massive weight loss leads an important excess of skin on thoracic level giving the aspect of a feminine breast with a relatively important ptose. Several techniques were described in the literature about gynaecomastia , but the post-bariatric pseudo-gynaecomastia was not handled yet enough. Moreover, there is no single consensual technique on this subject. The technique used in this service was described for the first time in 2008 ( 1 ) on a serie of 8 patients with an average follow-up of 13 months. Although the results are promising, no other publication was done, and the procedure remains badly represented in the world literature.
- Conditions
- Gynecomastia
- Being tested
- Inferior pédicule gynaecomastia
- Medical subject headings
- Gynecomastia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inferior pédicule gynaecomastiaProcedure or surgery
Inferior pédicule gynaecomastia
What is being measured
The primary outcome is the main question the study is designed to answer.
aesthetic result score
patient answer to a satisfaction questionnaire
Measured: Average of 6 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start14 Nov 2016
- Primary completion30 Sep 2017
- Study completion2 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GynecomastiaStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe LEVAN, MD, Study director, GHPSJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03319862
- Sponsor's protocol ID
- PEDINF
- Status last verified
- Oct 2017
- First submitted
- 16 Oct 2017
- Last updated
- 1 Mar 2018
- 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 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-massive Weight Loss Chest Contouring: Inferior Pedicle Technique in Pseudo-gynecomastia Correction
- ClinicalTrials.gov ID
- NCT03319862
- Acronym / sponsor ID
- PEDINF
- Conditions
- Gynecomastia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 14 Nov 2016 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 2 Nov 2017 (actual)
- First posted
- 24 Oct 2017 (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 massive weight loss leads an important excess of skin on thoracic level giving the aspect of a feminine breast with a relatively important ptose. Several techniques were described in the literature about gynaecomastia , but the post-bariatric pseudo-gynaecomastia was not handled yet enough. Moreover, there is no single consensual technique on this subject. The technique used in this service was described for the first time in 2008 ( 1 ) on a serie of 8 patients with an average follow-up of 13 months. Although the results are promising, no other publication was done, and the procedure remains badly represented in the world literature.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- every patient hospitalized for gynaecomastia but only whose have a inferior pedicle gynaecomastia are selected for the project.
Key inclusion criteria (2 listed)
- inferior pedicle gynaecomastia surgery
- Age > 16
Key exclusion criteria (1 listed)
- Age < 16
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 |
|---|---|---|
| Inferior pédicule gynaecomastiaInferior pédicule gynaecomastia | Procedure or surgery | – |
Primary outcome
aesthetic result score
Time frame: Average of 6 months post-surgery
patient answer to a satisfaction questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
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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. This study is not recruiting at the moment.
Philippe LEVAN, MD study director
GHPSJ
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 Gynecomastia, run by Fondation Hôpital Saint-Joseph 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 1 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: finished, as of the sponsor's last update on 1 Mar 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
aesthetic result score (time frame: Average of 6 months post-surgery). 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 1 Mar 2018.