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Veiligheid en haalbaarheid van gerobotiseerde SP-tepelsparende borstamputatie

30 september 2026 bijgewerkt door: Deborah Farr, MD

Veiligheid en haalbaarheid van gerobotiseerde tepelsparende mastectomie met één poort (SP): een enkele instelling, pilotproef met één arm

This is a single arm, single-center, prospective clinical trial designed to track the peri, post-operative and oncologic outcomes when utilizing the da-Vinci single port (SP) robotic platform to perform robotic nipple sparing mastectomy (rNSM) and immediate breast reconstruction with tissue expanders/implants and acellular dermal matrix (ADM - Alloderm), for patients with breast cancer as well as those with a high risk for breast cancer.

Safety and feasibility measures will be measured as primary outcome measures. Oncological and patient satisfaction outcome measures will be measured. Our hypothesis is that SPr-NSM is equal to open NSM in terms of safety, feasibility and oncological outcomes with improved patient satisfaction as measured by nipple sensation and patient reported outcomes.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

rNSM using the multi-port robotic platform followed by standard of care open breast reconstruction has been done successfully at multiple institutions worldwide with comparable, if not superior outcomes to an open surgical approach. This study explores this procedure with the Da Vinci SP robot with pre-pectoral reconstruction with acellular dermal matrix. The patients will be evaluated per standard of care post-operative visits at 2 weeks, 1 month, and every 6 months for five years post operatively for subjective patient satisfaction and objectively for post-operative nipple sensation. The patients will be monitored longitudinally for oncologic outcomes including the presence of a new breast cancer and/or breast cancer recurrence. Patients will be monitored for any complications related to rNSM and the use of ADM in expander and implant-based breast reconstruction.

Investigational Device:

The da Vinci SP Surgical System, Model SP1098 is a software-controlled, electro- mechanical system designed for surgeons to perform single port minimally invasive surgery. The Model SP1098 Surgical System consists of a Surgeon Console, a Patient Cart, and a Vision Cart, and is used with a Camera Instrument, EndoWrist SP Instruments, and Accessories.

Indications for Use:

The da Vinci SP Surgical System, Model SP1098 is cleared for use in urologic surgical procedures that are appropriate for a single-port approach and transoral otolaryngology procedures restricted to T1 and T2 tumors. This investigational study will evaluate device usage in nipple sparing mastectomy (NSM) procedures.

Studietype

Ingrijpend

Inschrijving (Geschat)

90

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • Texas
      • Dallas, Texas, Verenigde Staten, 75390
        • Werving
        • UT Southwestern
        • Contact:
          • Deborah E Farr, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 80 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

Inclusion Criteria:

  • Candidates for open nipple sparing mastectomy, per standard of care with regards to anatomic factors and tumor location including: nipple sparing resection and resection OR prophylactic mastectomy for risk reduction OR treatment of ductal carcinoma in-situ or clinically node negative cT1-T3 breast cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

  • Inability to provide informed consent
  • Pregnant or nursing women
  • Patients with:
  • Inflammatory breast cancer
  • Skin involvement with tumor
  • Pre-operative diagnosis of Nipple Areolar Complex (NAC) tumor involvement
  • Grade 3 or higher nipple ptosis
  • Contraindicated for general anesthesia or surgery
  • Heavy current smoking history (defined as > 20 cigarettes per day)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Treatment arm (SPrNSM)

Patients will undergo Single Port robotic Nipple Sparing Mastectomy (SPrNSM) with immediate breast reconstruction with tissue expanders/implants and acellular dermal matrix (Alloderm)
Apparaat: da Vinci SP Surgical System

This is a software-controlled, electro- mechanical system designed for surgeons to perform single port minimally invasive surgery.

Andere namen:
  • da Vinci SP chirurgisch systeem, model SP1098

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of participants who complete single port nipple sparing mastectomy (SPrNSM)
Tijdsspanne: Date of surgery (Day 1)

The number of participants who complete single port nipple sparing mastectomy (SPrNSM) will be measured.
Date of surgery (Day 1)
Incidence of perioperative complications
Tijdsspanne: 30 days following surgery

Perioperative complications will be described using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTACAE) v. 4.03 criteria. Complications will refer to any medical occurrence directly attributed to the surgical procedure during and within the first 30 days following use of the SP robotic platform and ADM. Grade 3, 4, or 5 complication or adverse event will constitute an event. Perioperative complication rates will be compared to historical complication rates.
30 days following surgery

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of participants with positive margins
Tijdsspanne: 2 weeks following date of surgery

The pathologist will assess margin status in patients undergoing SPrNSM
2 weeks following date of surgery
Number of participants with new breast cancers
Tijdsspanne: following date of surgery up to 5 years

The PI will assess new breast cancers.
following date of surgery up to 5 years
Number of participants with recurrent breast cancers
Tijdsspanne: following date of surgery up to 5 years

The PI will assess recurrent breast cancers.
following date of surgery up to 5 years
Patient satisfaction as measured by BREAST-Q reconstruction tool
Tijdsspanne: Baseline, postoperatively at 2 weeks, every 6 months for 5 years

Patient satisfaction is measured by BREAST-Q reconstruction tool at baseline, postoperatively at 2 weeks, and every 6 months for 5 years. BREAST-Q reconstruction module and Breast implant illness survey for patients. Questions about self-confidence, comfort, acceptance of new appearance, feeling of implants, breast pain. The score represents questionnaires about different domains and each question has four possible dimensions. The values of these dimensions varies from 1 (minimum score- worst outcome) to 4 or 5 (maximum score- best outcome) (Likert Scale) depending on part of the questionnaire .
Baseline, postoperatively at 2 weeks, every 6 months for 5 years
Patient satisfaction as measured by BREAST-Q sensation tool
Tijdsspanne: Baseline, postoperatively at 2 weeks, every 6 months for 5 years

Patient satisfaction is measured by BREAST-Q sensation tool at baseline, postoperatively at 2 weeks, and every 6 months for 5 years and it is another tool to help quantify breast sensation both pre-operatively and post-operatively. The Breast-Q is comprised of 2 domains - i) Satisfaction domains and ii) Well-being domains, which are further divided into sub-domains. We will be using 3 satisfaction sub-domains: i) Satisfaction with breasts ii) Satisfaction with Nipple iii) Satisfaction with outcome and 3 well-being sub-domains: i) Psychosocial well-being ii) Sexual well-being and iii) Physical well-being. The values range from 1 (minimum score- worst outcome) to 4 or 5 (maximum score- best outcome) (Likert Scale) depending on part of the questionnaire.
Baseline, postoperatively at 2 weeks, every 6 months for 5 years
Degree to which the patients maintain nipple sensation as measured by Semmes Weinstein monofilament tool at baseline
Tijdsspanne: Baseline, postoperatively at 2 weeks, every 6 months for 5 years

Degree to which the patients maintain nipple sensation will be measured by Semmes Weinstein monofilament tool at baseline, postoperatively at 2 weeks, and every 6 months for 5 years. Monofilament diameter and force will be measured at 9 different locations of the breast to determine the degree of sensation.
Baseline, postoperatively at 2 weeks, every 6 months for 5 years
Incidence of short term complications
Tijdsspanne: Post-operatively at 30 days

Reconstruction outcomes is measured by short term complications (wounds, infections, seromas, and device exchange or loss) that occur post-operatively after surgery Short term complications will be described using the NCI CTACAE v. 4.03 criteria.
Post-operatively at 30 days
Incidence of long term complications
Tijdsspanne: Following surgery up to 5 years

Long term complications will be described using the NCI CTACAE v. 4.03 criteria and will refer to any medical occurrence directly attributed to the surgical procedure up to 5 years following use of the SP robotic platform and ADM. Grade 3, 4, or 5 complication or adverse event will constitute an event.
Following surgery up to 5 years

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Deborah Farr, MD

Onderzoekers

  • Hoofdonderzoeker: Deborah Farr, MD, FACS, University of Texas Southwestern Medical Center

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

8 maart 2022

Primaire voltooiing (Geschat)

1 februari 2027

Studie voltooiing (Geschat)

1 februari 2027

Studieregistratiedata

Eerst ingediend

8 februari 2022

Eerst ingediend dat voldeed aan de QC-criteria

8 februari 2022

Eerst geplaatst (Werkelijk)

18 februari 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

30 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • STU-2022-0091

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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