Penile Girth AugmentationNCT07547839
Efficacy and Stability of Autologous Fat Grafting for Penile Girth Augmentation
A study testing Autologous Fat Grafting in people with Penile Girth Augmentation and Fat Graft, run by Assiut University.
Trial summary
The primary aim of this study is to evaluate the clinical and radiological efficacy and long-term stability of autologous fat grafting as a method for girth augmentation. The procedure involves extracting approximately 40-80 mL of fat from the patient's lower abdomen. Read more about this study
- Who is it for?
- Ages 21 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Penile Girth Augmentation, Fat Graft
- What is being tested?
- Autologous Fat Grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male individuals dissatisfied with their penile girth
- Mid-shaft penile circumference at flaccid state less than 11 cm
- Regular coital activity
- Age between 21-60 years old
Who cannot join
- Mid-shaft penile circumference at flaccid state more than 11 cm
- Congenital penile deformities
- Previous penile augmentation
- Inflammatory skin infection (balanitis)
- Blood disorder such as hemophilia, leukemia, or lymphoma
- Psychiatric disorder such as body dysmorphic disorder, bipolar disorder, obsessive compulsive disorder (OCD), or depression
About this study
Official title: Efficacy and Stability of Autologous Fat Grafting for Penile Girth Augmentation: Clinical and Radiologic Follow-up
The primary aim of this study is to evaluate the clinical and radiological efficacy and long-term stability of autologous fat grafting as a method for girth augmentation. The procedure involves extracting approximately 40-80 mL of fat from the patient's lower abdomen. This harvested fat is repeatedly washed , and then injected into the penile dartos layer to enhance penile circumference.
The study will enroll male individuals between 21-60 years old who have regular coital activity, are dissatisfied with their penile girth, and have a flaccid mid-shaft penile circumference of less than 11 cm.
Researchers will measure the clinical success of the procedure by tracking the mean change in penile mid-shaft circumference. Additionally, high-resolution ultrasonography will be used at 6 weeks post-operatively to objectively assess the survival and thickness of the transplanted fat layer. Finally, at a three-month follow-up, patient satisfaction will be evaluated to measure improvements in aesthetic outcomes and functional satisfaction.
Read the detailed description
Penile girth enhancement using autologous fat injection enhances penile circumference by transferring adipose tissue into the penile dartos layer. Because it utilizes the patient's own living tissue, autologous fat grafting has emerged as a preferred augmentation technique, it provides a natural, soft aesthetic while carrying a superior safety profile with no risk of foreign body rejection or allergic reaction.
A critical component of this trial is the integration of high-resolution ultrasonography (US) to objectively evaluate the survival and distribution of the grafted fat. While standard clinical tape measurements provide a general assessment of circumference, they often lack the precision required to distinguish actual fat graft retention from post-operative edema or inflammatory changes. Serial US evaluations allow researchers to quantify the exact distance between the skin and Buck's fascia, providing a standardized metric to track the rate of fat resorption over time. Furthermore, this radiologic approach enables the early detection of post-operative sequelae, such as fat necrosis, fibrotic nodules, or oil cysts, which may not be palpable during a physical examination.
Procedural Methodology
- Harvesting: Following the instillation of a tumescent physiological solution, approximately 40-80 mL of fat is harvested from the patient's lower abdomen using a multiperforated cannula.
- Refinement: The extracted fat is repeatedly washed with sterile saline to remove blood and debris. To ensure smooth injection, it undergoes mechanical refinement via luer-to-luer connectors to progressively reduce the globule size.
- Transfer: The purified fat is transferred to 3-mL syringes and injected into the subdartos space across four quadrants using a blunt 18-gauge cannula to ensure placement just above the tunica albuginea. The fat is deposited in vertical lines utilizing a retrograde injection technique.
- Recovery: Patients are instructed to abstain from intercourse for 4 weeks post-procedure to allow for initial graft stabilization.
- Conditions
- Penile Girth Augmentation, Fat Graft
- Being tested
- Autologous Fat Grafting
- Keywords
- Penile Girth Augmentation, Autologous Fat Grafting, Fat Transfer, Penile Enhancement, Ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Fat GraftingProcedure or surgery
Approximately 40-80 mL of body fat is harvested from the patient's lower abdomen using a multiperforated cannula. The harvested fat is repeatedly washed with sterile physiological saline to remove blood and debris, then undergoes mechanical refinement to reduce globule size. Finally, the refined fat is transferred to 3-mL syringes and injected into the four quadrants of the penile dartos layer (just above the tunica albuginea) using a blunt 18-gauge cannula.
| Study group | Role | What they receive |
|---|---|---|
| Autologous Fat Grafting | Experimental | Participants in this arm will undergo penile girth enhancement via autologous fat grafting. Approximately 40-80 mL of fat will be harvested from the patient's lower abdomen using a multiperforated cannula. The fat is then purified with physiological saline and mechanically refined to reduce globule size. Finally, the prepared fat is injected into the penile subdartos space across four quadrants using a blunt 18-gauge cannula to ensure uniform distribution. Receives: Procedure: Autologous Fat Grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Flaccid Penile Mid-Shaft Circumference
Measurement of the change in penile mid-shaft circumference, assessed in centimeters (cm) using a clinical tape measure. The measurement is taken in the flaccid state to evaluate the clinical efficacy of the girth augmentation by comparing post-operative dimensions to the pre-operative baseline.
Measured: Baseline and 6 weeks post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Penile Girth AugmentationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Assem Hussein, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07547839
- Sponsor's protocol ID
- Fat Graft for Penile Girth
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Stability of Autologous Fat Grafting for Penile Girth Augmentation: Clinical and Radiologic Follow-up
- ClinicalTrials.gov ID
- NCT07547839
- Acronym / sponsor ID
- Fat Graft for Penile Girth
- Conditions
- Penile Girth Augmentation, Fat Graft
- Keywords
- Penile Girth Augmentation, Autologous Fat Grafting, Fat Transfer, Penile Enhancement, Ultrasonography
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 23 Apr 2026 (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 primary aim of this study is to evaluate the clinical and radiological efficacy and long-term stability of autologous fat grafting as a method for girth augmentation. The procedure involves extracting approximately 40-80 mL of fat from the patient's lower abdomen. This harvested fat is repeatedly washed , and then injected into the penile dartos layer to enhance penile circumference.
The study will enroll male individuals between 21-60 years old who have regular coital activity, are dissatisfied with their penile girth, and have a flaccid mid-shaft penile circumference of less than 11 cm.
Researchers will measure the clinical success of the procedure by tracking the mean change in penile mid-shaft circumference. Additionally, high-resolution ultrasonography will be used at 6 weeks post-operatively to objectively assess the survival and thickness of the transplanted fat layer. Finally, at a three-month follow-up, patient satisfaction will be evaluated to measure improvements in aesthetic outcomes and functional satisfaction.
Detailed description
Penile girth enhancement using autologous fat injection enhances penile circumference by transferring adipose tissue into the penile dartos layer. Because it utilizes the patient's own living tissue, autologous fat grafting has emerged as a preferred augmentation technique, it provides a natural, soft aesthetic while carrying a superior safety profile with no risk of foreign body rejection or allergic reaction.
A critical component of this trial is the integration of high-resolution ultrasonography (US) to objectively evaluate the survival and distribution of the grafted fat. While standard clinical tape measurements provide a general assessment of circumference, they often lack the precision required to distinguish actual fat graft retention from post-operative edema or inflammatory changes. Serial US evaluations allow researchers to quantify the exact distance between the skin and Buck's fascia, providing a standardized metric to track the rate of fat resorption over time. Furthermore, this radiologic approach enables the early detection of post-operative sequelae, such as fat necrosis, fibrotic nodules, or oil cysts, which may not be palpable during a physical examination.
Procedural Methodology
- Harvesting: Following the instillation of a tumescent physiological solution, approximately 40-80 mL of fat is harvested from the patient's lower abdomen using a multiperforated cannula.
- Refinement: The extracted fat is repeatedly washed with sterile saline to remove blood and debris. To ensure smooth injection, it undergoes mechanical refinement via luer-to-luer connectors to progressively reduce the globule size.
- Transfer: The purified fat is transferred to 3-mL syringes and injected into the subdartos space across four quadrants using a blunt 18-gauge cannula to ensure placement just above the tunica albuginea. The fat is deposited in vertical lines utilizing a retrograde injection technique.
- Recovery: Patients are instructed to abstain from intercourse for 4 weeks post-procedure to allow for initial graft stabilization.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous Fat Grafting | Experimental | Procedure: Autologous Fat GraftingParticipants in this arm will undergo penile girth enhancement via autologous fat grafting. Approximately 40-80 mL of fat will be harvested from the patient's lower abdomen using a multiperforated cannula. The fat is then purified with physiological saline and mechanically refined to reduce globule size. Finally, the prepared fat is injected into the penile subdartos space across four quadrants using a blunt 18-gauge cannula to ensure uniform distribution. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male individuals dissatisfied with their penile girth
- Mid-shaft penile circumference at flaccid state less than 11 cm
- Regular coital activity
- Age between 21-60 years old
Key exclusion criteria (6 listed)
- Mid-shaft penile circumference at flaccid state more than 11 cm
- Congenital penile deformities
- Previous penile augmentation
- Inflammatory skin infection (balanitis)
- Blood disorder such as hemophilia, leukemia, or lymphoma
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 |
|---|---|---|
| Autologous Fat GraftingApproximately 40-80 mL of body fat is harvested from the patient's lower abdomen using a multiperforated cannula. The harvested fat is repeatedly washed with sterile physiological saline to remove blood and debris, then undergoes mechanical refinement to reduce globule size. Finally, the refined fat is transferred to 3-mL syringes and injected into the four quadrants of the penile dartos layer (just above the tunica albuginea) using a blunt 18-gauge cannula. | Procedure or surgery | Autologous Fat Grafting |
Primary outcome
Change in Flaccid Penile Mid-Shaft Circumference
Time frame: Baseline and 6 weeks post-operatively
Measurement of the change in penile mid-shaft circumference, assessed in centimeters (cm) using a clinical tape measure. The measurement is taken in the flaccid state to evaluate the clinical efficacy of the girth augmentation by comparing post-operative dimensions to the pre-operative baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Fat Grafting in people with Penile Girth Augmentation and Fat Graft, run by Assiut University.
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Flaccid Penile Mid-Shaft Circumference (time frame: Baseline and 6 weeks post-operatively). 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 23 Apr 2026.