Breast SaggingNCT02201979
Laser Fluorescent Imaging of Nipple and Areola During Breast Lift
An observational study of Breast Sagging and Ptosis, run by Swanson Center at 1 site in United States.
Trial summary
Breast lift surgery performed in combination with breast implants is a common cosmetic operation. However, there have been concerns regarding the safety of this treatment combination. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Sagging, Ptosis, Loss of Breast Volume
- What is being tested?
- Vertical breast lift with implants
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Nov 2014
- 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 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult women undergoing cosmetic breast lifts in combination with implants.
Who may be able to join
- Women aged 18 - 80
- Consent for participation
Who cannot join
- history of allergy to iodinated contrast dye -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laser Fluorescent Imaging of Nipple and Areola During Breast Lift in Combination With Breast Implants
Breast lift surgery performed in combination with breast implants is a common cosmetic operation. However, there have been concerns regarding the safety of this treatment combination. Some investigators are concerned that an implant may increase the risk of complications, including loss of circulation to the nipple and areola. This study was undertaken to evaluate the blood supply of the breast using intraoperative laser fluorescent imaging and to determine whether a breast implant compromises blood supply to the nipple and areola.
Read the detailed description
Protocol
Laser Fluorescent Imaging of Breasts During Vertical Breast Lifts and Reductions Performed in Combination with Breast Implants.
Background/Purpose
Today, breast lifts are a common operation. Implants may be recommended to provide greater fullness of the upper poles of the breasts. One of the risks of surgery is compromised circulation to the nipples and areolae. Some investigators believe that the simultaneous insertion of breast implants adds to the risk by causing pressure on the overlying breast tissue and skin.1 Staging the procedure (first the breast lift and then implants or vice versa) has been recommended, but staging is inconvenient and costly for patients, necessitating two operations. Clinical experience with the newer vertical breast lift technique, as opposed to the traditional inferior pedicle technique, has been favorable, with few reported complications.2 The vertical technique uses a shorter, more superficial pedicle than the traditional inferior pedicle, with a more reliable blood supply.2 A breast lift and reduction are essentially the same operation; more breast tissue is removed during a reduction but the dissection is the same.
This study was undertaken to investigate the blood supply to the nipples and areolae during the combined breast lift/reduction and implants procedure. Laser fluorescent imaging represents an objective measurement technique that has been used for several years to monitor the vascularity of flaps used in breast reconstruction.
Subjects
Fifteen consecutive consenting adult women undergoing outpatient elective breast lifts or reductions in combination with breast implants will be investigated. By testing the blood supply at two time points, the patient serves as her own control.
Imaging
The SPY Elite Intraoperative Perfusion Assessment System (Lifecell Corp., Branchburg, NJ) consists of a near-infrared laser that detects fluorescence. The imaging agent, indocyanine green, is absorbed at 800-810 nm. The imaging agent is injected intravenously. Starting within 5-10 seconds of injection, the system records images of the breasts, showing the fluorescence, which indicates blood supply. The half-life of the imaging agent is 2.5-3 minutes.
Surgery
The implants are inserted and the breast lift/reduction procedure is performed on both sides using the vertical technique.2 The implants are not inflated. The filling tubes are left in place. At this point, 3 mL (7.5 mg) of indocyanine green is injected and the image is recorded, documenting blood supply to both breasts. Next, the implants are inflated using the filling tubes. After inflation of the implants, the breasts are reimaged, with the filling tubes still in place. Once adequate circulation is demonstrated, the filling tubes are removed. In the unlikely event that inadequate circulation is found during imaging, the implant volume may be reduced accordingly, and a third image taken to confirm adequate circulation to the nipples.
Null Hypothesis
A breast lift or reduction performed using the vertical technique in combination with insertion of breast implants does not compromise circulation to the nipples and areolae and may be safely performed simultaneously, avoiding a need for staged surgery.
Informed Consent
Patients are informed as to the nature of the study and are told that their participation is entirely voluntary and they are free to decline, and that doing so does not in any way prejudice their treatment. Patients are informed of the small risk of an allergic reaction that will be treated if it occurs.
Patient Risk
There is no patient risk apart from a very small risk of allergic reaction, which is further reduced by excluding any patient with a known allergy to iodinated contrast dye. The study does not affect patient treatment. It offers the possibility of detection of reduced skin circulation, information that can be used by the surgeon to limit implant volume, or forego their simultaneous insertion if necessary and reduce the risk of tissue loss and delayed wound healing, known complications of breast lifts and reductions.
Sample Size
A sample of 15 patients is anticipated, treated over a period of approximately 5 months.
Disclosure
The author has no financial interest in any of the products, devices, or drugs mentioned in this article. The author has no conflicts of interest to disclose. There was no outside funding for this study.
- Conditions
- Breast Sagging, Ptosis, Loss of Breast Volume
- Being tested
- Vertical breast lift with implants
- Keywords
- breast, ptosis, sagging, implant, lift
- Medical subject headings
- Blepharoptosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vertical breast lift with implantsProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Breast lift in combination with implants. | Patients undergoing breast lifts in combination with implants are studied using laser fluorescent imaging to evaluate blood supply. Receives: Procedure: Vertical breast lift with implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood supply to breast as evaluated by laser fluorescent imaging
Laser fluorescent imaging is used to evaluate breast blood supply.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast SaggingStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swanson Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Swanson, M.D., Swanson Center
- Investigators
- Eric Swanson, M.D., Principal investigator, Swanson Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02201979
- Sponsor's protocol ID
- Swanson 004
- Status last verified
- Nov 2014
- First submitted
- 24 Jul 2014
- Last updated
- 20 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Swanson E. Prospective comparative clinical evaluation of 784 consecutive cases of breast augmentation and vertical mammaplasty, performed individually and in combination. Plast Reconstr Surg. 2013 Jul;132(1):30e-45e. doi: 10.1097/PRS.0b013e3182910b2e.
PubMed 23806952
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Fluorescent Imaging of Nipple and Areola During Breast Lift in Combination With Breast Implants
- ClinicalTrials.gov ID
- NCT02201979
- Acronym / sponsor ID
- Swanson 004
- Conditions
- Breast Sagging, Ptosis, Loss of Breast Volume
- Keywords
- breast, ptosis, sagging, implant, lift
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Swanson CenterUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 28 Jul 2014 (estimated)
- 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.
Breast lift surgery performed in combination with breast implants is a common cosmetic operation. However, there have been concerns regarding the safety of this treatment combination. Some investigators are concerned that an implant may increase the risk of complications, including loss of circulation to the nipple and areola. This study was undertaken to evaluate the blood supply of the breast using intraoperative laser fluorescent imaging and to determine whether a breast implant compromises blood supply to the nipple and areola.
Detailed description
Protocol
Laser Fluorescent Imaging of Breasts During Vertical Breast Lifts and Reductions Performed in Combination with Breast Implants.
Background/Purpose
Today, breast lifts are a common operation. Implants may be recommended to provide greater fullness of the upper poles of the breasts. One of the risks of surgery is compromised circulation to the nipples and areolae. Some investigators believe that the simultaneous insertion of breast implants adds to the risk by causing pressure on the overlying breast tissue and skin.1 Staging the procedure (first the breast lift and then implants or vice versa) has been recommended, but staging is inconvenient and costly for patients, necessitating two operations. Clinical experience with the newer vertical breast lift technique, as opposed to the traditional inferior pedicle technique, has been favorable, with few reported complications.2 The vertical technique uses a shorter, more superficial pedicle than the traditional inferior pedicle, with a more reliable blood supply.2 A breast lift and reduction are essentially the same operation; more breast tissue is removed during a reduction but the dissection is the same.
This study was undertaken to investigate the blood supply to the nipples and areolae during the combined breast lift/reduction and implants procedure. Laser fluorescent imaging represents an objective measurement technique that has been used for several years to monitor the vascularity of flaps used in breast reconstruction.
Subjects
Fifteen consecutive consenting adult women undergoing outpatient elective breast lifts or reductions in combination with breast implants will be investigated. By testing the blood supply at two time points, the patient serves as her own control.
Imaging
The SPY Elite Intraoperative Perfusion Assessment System (Lifecell Corp., Branchburg, NJ) consists of a near-infrared laser that detects fluorescence. The imaging agent, indocyanine green, is absorbed at 800-810 nm. The imaging agent is injected intravenously. Starting within 5-10 seconds of injection, the system records images of the breasts, showing the fluorescence, which indicates blood supply. The half-life of the imaging agent is 2.5-3 minutes.
Surgery
The implants are inserted and the breast lift/reduction procedure is performed on both sides using the vertical technique.2 The implants are not inflated. The filling tubes are left in place. At this point, 3 mL (7.5 mg) of indocyanine green is injected and the image is recorded, documenting blood supply to both breasts. Next, the implants are inflated using the filling tubes. After inflation of the implants, the breasts are reimaged, with the filling tubes still in place. Once adequate circulation is demonstrated, the filling tubes are removed. In the unlikely event that inadequate circulation is found during imaging, the implant volume may be reduced accordingly, and a third image taken to confirm adequate circulation to the nipples.
Null Hypothesis
A breast lift or reduction performed using the vertical technique in combination with insertion of breast implants does not compromise circulation to the nipples and areolae and may be safely performed simultaneously, avoiding a need for staged surgery.
Informed Consent
Patients are informed as to the nature of the study and are told that their participation is entirely voluntary and they are free to decline, and that doing so does not in any way prejudice their treatment. Patients are informed of the small risk of an allergic reaction that will be treated if it occurs.
Patient Risk
There is no patient risk apart from a very small risk of allergic reaction, which is further reduced by excluding any patient with a known allergy to iodinated contrast dye. The study does not affect patient treatment. It offers the possibility of detection of reduced skin circulation, information that can be used by the surgeon to limit implant volume, or forego their simultaneous insertion if necessary and reduce the risk of tissue loss and delayed wound healing, known complications of breast lifts and reductions.
Sample Size
A sample of 15 patients is anticipated, treated over a period of approximately 5 months.
Disclosure
The author has no financial interest in any of the products, devices, or drugs mentioned in this article. The author has no conflicts of interest to disclose. There was no outside funding for this study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast lift in combination with implants. | – | Procedure: Vertical breast lift with implantsPatients undergoing breast lifts in combination with implants are studied using laser fluorescent imaging to evaluate blood supply. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult women undergoing cosmetic breast lifts in combination with implants.
Key inclusion criteria (2 listed)
- Women aged 18 - 80
- Consent for participation
Key exclusion criteria (1 listed)
- history of allergy to iodinated contrast dye -
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 |
|---|---|---|
| Vertical breast lift with implants | Procedure or surgery | Breast lift in combination with implants. |
Primary outcome
Blood supply to breast as evaluated by laser fluorescent imaging
Time frame: 5 months
Laser fluorescent imaging is used to evaluate breast blood supply.
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 20 Nov 2014.
- Background: PubMed 23806952Swanson E. Prospective comparative clinical evaluation of 784 consecutive cases of breast augmentation and vertical mammaplasty, performed individually and in combination. Plast Reconstr Surg. 2013 Jul;132(1):30e-45e. doi: 10.1097/PRS.0b013e3182910b2e.
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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.
Eric Swanson, M.D. principal investigator
Swanson Center
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 Breast Sagging and Ptosis, run by Swanson Center at 1 site in United States.
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 20 Nov 2014. 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 United States. 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?
Blood supply to breast as evaluated by laser fluorescent imaging (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02201979, which also lists 1 linked publication.
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 20 Nov 2014; AzTrials last refreshed its copy on 8 Nov 2026.