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New endoscopic technique could simplify breast reconstruction after mastectomy

NCT ID NCT07602868

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 263 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

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

18 to 70 years

Sex

Female participants only

Healthy volunteers

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

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

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  1. The official record

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