New endoscopic technique could simplify breast reconstruction after mastectomy
NCT ID NCT07602868
First seen Jun 24, 2026 · Last updated Aug 05, 2026 · Updated 3 times
Summary
This study will compare a newer, less invasive endoscopic breast reconstruction method (direct-to-implant) with traditional flap surgery (using tissue from the abdomen) in 588 women who had a mastectomy at least one year ago. The goal is to see if the endoscopic approach leads to fewer complications, better cosmetic results, and higher quality of life. The study is not yet recruiting and will follow participants over time to assess outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- endoscopic direct-to-implant breast reconstruction procedure
- What this could lead to
- If successful, this could offer a less invasive, single-surgery option for breast reconstruction after mastectomy, reducing recovery time and scarring compared to flap surgery.
- What could go wrong
- This is an early-stage study (prospective cohort) with no random assignment, so results may be biased. The new technique may have higher complication rates or lower patient satisfaction than expected.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 263 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
This technique, developed as an original procedure by our team, is performed through an axillary incision using a gas-inflated endoscopic approach. It breakthroughly integrates the traditional two-stage operation into a single-stage procedure.First, the retropectoral plane is dissected using a reverse-sequence technique. Postoperatively, intentional fluid accumulation within the implant pocket is utilized to expand the skin envelope. This achieves significantly greater tissue expansion compared to conventional tissue expanders, resulting in a reconstructed breast with a more natural contour and softer tissue consistency.Second, the entire procedure strategically avoids creating any new incisions within the breast region itself. This significantly reduces the risks of wound dehiscence and surgical site infection, while simultaneously shortening the postoperative recovery period.
- Ages
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18 to 70 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Female patients aged 18-70 years * One year after Modified Radical Mastectomy (MRM), Nipple-Sparing Mastectomy (NSM), or Skin-Sparing Mastectomy (SSM), or six months after the completion of radiotherapy, provided the local skin remains viable and sufficiently lax; * voluntary participation and ability to provide written informed consent. Exclusion Criteria: * History of breast surgery in which the pectoralis major muscle was removed; * Patients with serious preoperative co-morbidities and poor general condition who cannot tolerate the surgery; * Diabetes mellitus with a long history of smoking or combined poor glycemic control; * current enrollment in other clinical trials that may interfere with study outcomes; * Review (clinical, imaging, pathological basis) reveals the presence of local/regional recurrence or uncontrollable distant metastasis.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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