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Can a new Armpit-Incision technique make breast reconstruction safer and easier?

NCT ID NCT07757074

Disease control Sponsor: Du Zhenggui Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This study compares two ways to rebuild a breast after a mastectomy for breast cancer: a newer, minimally invasive endoscopic method done through a small armpit incision, versus the traditional latissimus dorsi flap surgery (using muscle from the back, often with an implant). The goal is to see which approach gives women better aesthetic results, fewer complications, and a faster recovery. The trial will follow women aged 18-70 who have already had a mastectomy and are now seeking delayed reconstruction.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Two surgical procedures: minimally invasive endoscopic direct-to-implant reconstruction via the armpit versus latissimus dorsi flap with or without implant
What this could lead to
If successful, this could offer a less invasive, faster-recovering, and more cost-effective option for women seeking delayed breast reconstruction after mastectomy, improving their quality of life.
What could go wrong
This is an observational study, not a randomized trial, so results may be influenced by patient selection. The new technique may carry risks like skin injury, infection, or implant complications, and long-term outcomes are not yet known.

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 268 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

Sep 2028

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

Collecting the data of breast cancer patients who visited our hospital and the cooperative units from 2026 to 2027.

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 (inclusive) who have undergone simple mastectomy for breast cancer; * Patients with good local flap viability and laxity one year after total mastectomy or six months after completion of radiotherapy; * Patients who are able and willing to sign the informed consent form. Exclusion Criteria: * Recurrence detected on follow-up (based on clinical, imaging, or pathological findings), including local/regional recurrence or uncontrollable distant metastasis; * Patients who had the pectoralis major muscle resected during the initial mastectomy; * History of thoracic or back surgery with suspected damage to the thoracodorsal vessels; * Poor general condition and inability to tolerate surgery; * Presence of severe comorbidities, such as uncontrolled diabetes, severe bone marrow suppression after breast cancer treatment, compromised immune function, or a history of long-term smoking; * Participation in other clinical studies that may interfere with this trial.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • West China hospital of Sichuan University

    Chengdu, Sichuan, 610000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.