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Breast Cancer FemaleRCENSM-RNCT04049305

Robotic Versus Conventional or Endoscopic Nipple Sparing Mastectomy for Breast Cancer

A study testing Robotic assisted nipple sparing mastectomy (R-NSM), conventional nipple sparing mastectomy (C-NSM) and Endoscopic assisted nipple sparing mastectomy (E-NSM) in people with Breast Cancer Female, run by Changhua Christian Hospital at 13 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This study will retrospectively collect and evaluate the surgical outcomes of robotic nipple sparing mastectomy (R-NSM) compared with endoscopic assisted NSM (E-NSM) or conventional NSM (C-NSM) in the management of breast cancer. Read more about this study

Who is it for?
Ages 20 to 80 years, women only
Conditions the study is for
Breast Cancer Female
What is being tested?
Robotic assisted nipple sparing mastectomy (R-NSM), conventional nipple sparing mastectomy (C-NSM) and Endoscopic assisted nipple sparing mastectomy (E-NSM)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
900 participants
Where
13 sitesin 3 countries
Study dates
22 Aug 2019to 31 Dec 2021
Phase
Interventional
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 20 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A. Indications and selection criteria for nipple sparing mastectomy (NSM) in general and conventional nipple sparing mastectomy (C-NSM).
  • NSM will be offered to patients who are suitable for mastectomy but keen to conserve nipple areolar complex (NAC), with or without reconstruction. Patients must not have clinical or radiological involvement of the NAC. Patients with nipple involvement proven via intra-operative frozen section analysis will receive NAC excision and hence a skin-sparing mastectomy (SSM) performed instead. B. Indications and selection criteria for robotic nipple sparing mastectomy (R-NSM) or endoscopic nipple sparing mastectomy (E-NSM)
  • The general inclusion criteria or pre-requisite for nipple sparing mastectomy apply to R-NSM or E-NSM as well.
  • In addition, R-NSM or E-NSM should only include early stage breast cancer (carcinoma in situ, stage I - III A), a tumor size less than 5 cm, no evidence of multiple lymph node metastasis, and no evidence of nipple, skin or chest wall invasion.

Who cannot join

  • Contraindications for R-NSM, C-NSM or E-NSM include those with apparent NAC involvement, inflammatory breast cancer, breast cancer with chest wall or skin invasion, locally advanced breast cancer, breast cancer with extensive axillary lymph node metastasis (stage III B or later), and patients with severe co-morbid conditions, such as heart disease, renal failure, liver dysfunction, and poor performance status as assessed by the primary physicians.
  • Relative contraindications include women with large (breast cup size larger than E or breast mastectomy weight >600gm) or ptotic breast as the aesthetic outcomes may be sub-optimal.

Trial locations and contacts

13 sites in 3 countries.

Hung-Wen Lai, MD, PhD contact

+886933496822

hwlai650420@yahoo.com.tw

Shu-Hsin Pai, MD, PhD contact

+88647238595 ext. 8383

69584@cch.org.tw

13 sites in 3 countries

Taiwan11 sites, 11 recruiting

  • Changhua Christian Hospital

    Changhua

    Hung-Wen Lai, MD, PhD, +886933496822, hwlai650420@yahoo.com.tw

    Hung-Wen Lai, MD, PhD

    Recruiting

  • Kaohsiung Medical University Hospital

    Kaohsiung City

    Fu Ou-Yang, MD, PhD, kmufrank@gmail.com

    Fang-Ming Chen, MD, PhD, fchen@kmu.edu.tw

    Recruiting

  • China Medical University Hospital

    Taichung

    Liang-Chih Liu, MD, PhD, dr0363@yahoo.com.tw

    Liang-Chih Liu, MD, PhD

    Recruiting

  • National Cheng Kung University Hospital

    Tainan

    Yao-Lung Kuo, MD, PhD, ylkuo@mail.ncku.edu.tw

    Yao-Lung Kuo, MD, PhD

    Not yet recruiting

  • National Taiwan University Hospital

    Taipei

    Chiun-Sheng Huang, MD, PhD, huangcs@ntu.edu.tw

    Chiun-Sheng Huang, MD, PhD

    Not yet recruiting

  • Shin Kong Wu Ho-Su Memorial Hospital

    Taipei

    Tsui-Fen Cheng, MD, Sgtw88@gmail.com

    Tsui-Fen Cheng, MD

    Recruiting

  • Taipei Municipal Wan Fang Hospital

    Taipei

    Wei-Wen Chang, MD, weiwenabow@gmail.com

    Wei-Wen Chang, MD

    Not yet recruiting

  • Taipei Veterans General Hospital

    Taipei

    Ling-Ming Tseng, MD, lmtseng@vgptpe.gov.tw

    Ling-Ming Tseng, MD

    Not yet recruiting

  • Tri-Service General Hospital

    Taipei

    Guo-Shiou Liao, MD, guoshiou@ndmctsgh.edu.tw

    Guo-Shiou Liao, MD

    Recruiting

  • Shuang-Ho Hospital - Taipei Medical University

    Taipei County

    Chin-sheng Hung, MD, PhD, +886-2-27372181 ext. 8123, hungcs@tmu.edu.tw

    Chin-sheng Hung, MD, PhD

    Recruiting

  • Chang Gung Memorial Hospital

    Taoyuan

    Wen-Ling Kuo, MD, PhD, sylvie5285@gmail.com

    Wen-Ling Kuo, MD, PhD

    Not yet recruiting

Other trials in Taiwan

Italy1 site, 1 recruiting

  • European Institute of Oncology

    Milan

    Antonio Toesca, MD, antonio.toesca@ieo.it

    Antonio Toesca, MD

    Not yet recruiting

Other trials in Italy

South Korea1 site, 1 recruiting

  • Severance Hospital

    Seoul

    Hyung-Seok Park, MD, PhD, imgenius@yuhs.ac

    Hyung-Seok Park, MD, PhD

    Not yet recruiting

Other trials in South Korea

About this study

Official title: Robotic Versus Conventional or Endoscopic Nipple Sparing Mastectomy in the Management of Breast Cancer- A Retrospective Study With Multi-center Pooled Data Analysis

This study will retrospectively collect and evaluate the surgical outcomes of robotic nipple sparing mastectomy (R-NSM) compared with endoscopic assisted NSM (E-NSM) or conventional NSM (C-NSM) in the management of breast cancer. Multi-centers pooled data analysis would be performed for comparisons of R-NSM compared with C-NSM or E-NSM.

Read the detailed description

Nipple-sparing mastectomy (NSM), which preserved the nipple areolar complex (NAC) and skin flap during mastectomy, was increasingly performed in breast cancer patients due to better cosmetic outcome, higher patient satisfaction, and maintained oncologic safety. Minimal invasive surgery had become the main stream of operations, and new surgical innovations of NSM, like endoscopic nipple sparing mastectomy (E-NSM) or robotic nipple sparing mastectomy (R-NSM), were emerging and applied in the surgical treatment of breast cancer. E-NSM, which is performed through small axillary and/or peri-areolar incisions, was reported to be associated with small inconspicuous incision and good cosmetic outcome. Conventional E-NSM was performed with two separate incisions over axilla and peri-areolar regions. E-NSM with areolar incision, just like NSM with areolar related incision (NAC ischemia/necrosis rate: range 7%-81.8%), was associated with increased NAC ischemia/necrosis (reported ranged: 9.1-19%). New technique modifications of E-NSM were emerging focusing on single axillary incision NSM, which spare the peri-areolar incision and thereby decrease the compromise of bloody supply from mastectomy skin flap, was reported to have low NAC necrosis rate (0%). However, the 2-dimensional endoscopic in-line camera produces an inconsistent optical window around the curvature of the breast skin flap, and the internal mobility was limited and the dissection angles were inadequate with traditional endoscopic rigid tips instruments through single access. Due to the limitations of endoscopy instruments and technique difficulty, neither conventional E-NSM nor single access E-NSM was widespread used in breast cancer R-NSM, which introduce da Vinci surgical platform through a small extramammary axillary or lateral chest wound to perform NSM, had been applied in the surgical treatment of early breast cancer or risk reducing mastectomy. R-NSM, which incorporated 3- dimensional (3D) imaging system and flexibility of robotic arm and instruments, was reported to have the potential to overcome the technique difficulty of E-NSM. The preliminary results of R-NSM from current literature reported series and ours were safe, and associated with good cosmetic outcome and high patients' satisfaction. However, evidence comparing R-NSM to conventional NSM (CNSM) or E-NSM was lacking. In this study, the authors aim to investigate and analyze the clinical and aesthetic outcomes as well as the cost effectiveness of R-NSM through a longitudinal cohort study design whereby a retrospective review will be carried out for patients undergoing R-NSM, E-NSM or C-NSM. Multi-centers pooled data analysis would be performed for comparisons of R-NSM compared with C-NSM or E-NSM.

Being tested
Robotic assisted nipple sparing mastectomy (R-NSM), conventional nipple sparing mastectomy (C-NSM), Endoscopic assisted nipple sparing mastectomy (E-NSM)
Keywords
nipple sparing mastectomy, robotic nipple sparing mastectomy (R-NSM), conventional nipple sparing mastectomy (C-NSM), endoscopic assisted nipple sparing mastectomy (E-NSM), immediate breast reconstruction, immediate prothesis breast reconstruction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Robotic assisted nipple sparing mastectomy (R-NSM)Device

    R-NSM, which introduce da Vinci surgical platform through a small extra-mammary axillary or lateral chest wound to perform NSM, had been applied in the surgical treatment of early breast cancer or risk reducing mastectomy. R-NSM, which incorporated 3-dimensional (3D) imaging system and flexibility of robotic arm and instruments, was reported to have the potential to overcome the technique difficulty of E-NSM.

  • conventional nipple sparing mastectomy (C-NSM)Procedure or surgery

    Nipple-sparing mastectomy (NSM), which preserved the nipple areolar complex (NAC) and skin flap during mastectomy, was increasingly performed in breast cancer patients due to better cosmetic outcome, higher patient satisfaction, and maintained oncologic safety.

  • Endoscopic assisted nipple sparing mastectomy (E-NSM)Procedure or surgery

    E-NSM, which is performed through small axillary and/or peri-areolar incisions, was reported to be associated with small inconspicuous incision and good cosmetic outcome. Conventional E-NSM was performed with two separate incisions over axilla and peri-areolar regions. E-NSM with areolar incision, just like NSM with areolar related incision (NAC ischemia/necrosis rate: range 7%-81.8%), was associated with increased NAC ischemia/necrosis (reported ranged: 9.1-19%). New technique modifications of E-NSM were emerging focusing on single axillary incision NSM, which spare the peri-areolar incision and thereby decrease the compromise of bloody supply from mastectomy skin flap, was reported to have low NAC necrosis rate (0%).

Study groups in NCT04049305
Study groupRoleWhat they receive
Robotic assisted nipple sparing mastectomy (R-NSM)ExperimentalR-NSM, which introduce da Vinci surgical platform through a small extra-mammary axillary or lateral chest wound to perform NSM.
Receives: Device: Robotic assisted nipple sparing mastectomy (R-NSM)
Conventional nipple sparing mastectomy (C-NSM)Active comparatorNipple-sparing mastectomy (NSM), which preserved the nipple areolar complex (NAC) and skin flap during mastectomy.
Receives: Procedure: conventional nipple sparing mastectomy (C-NSM)
Endoscopic assisted nipple sparing mastectomy (E-NSM)Active comparatorE-NSM, which is performed through small axillary and/or peri-areolar incisions, with endoscopic instruments to performed nipple sparing mastectomy.
Receives: Procedure: Endoscopic assisted nipple sparing mastectomy (E-NSM)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Operation time

    Overall operation time (minute), from skin incision to completion of operations. Compared overall operation time between R-NSM, C-NSM and E-NSM.

    Measured: immediate post operation

  2. Wound healing status

    rate of Delayed wound healing between R-NSM, C-NSM and E-NSM groups.

    Measured: within one month (30 days) post operation

  3. Skin blister formation

    rate of skin blister formation between R-NSM, C-NSM and E-NSM groups.

    Measured: within one month (30 days) post operation

  4. Skin flap ischemia/necrosis rate

    rate of skin flap ischemia/necrosis between R-NSM, C-NSM and E-NSM groups.

    Measured: within one month (30 days) post operation

  5. Implant loss rate

    rate of implant loss between R-NSM, C-NSM and E-NSM groups.

    Measured: within one month (30 days) post operation

  6. Post operation Bleeding/hematoma rate

    rate of post operative bleeding/hematoma rate between R-NSM, C-NSM and E-NSM groups.

    Measured: within one month (30 days) post operation

  7. Post operation Bleeding/hematoma rate

    rate of post operative bleeding/hematoma between R-NSM, C-NSM and E-NSM groups.

    Measured: within one month (30 days) post operation

  8. Seroma formation rate

    rate of post operative seroma formation needing repeat aspiration between R-NSM, C-NSM and E-NSM groups.

    Measured: within one month (30 days) post operation

  9. Grade of Nipple areolar complex ischemia/necrosis

    The perfusion of NAC was evaluated in 2 weeks to 3 months post operation. The survival of NAC was confirmed at post-operative 3 months.

    The NAC ischemia/necrosis was divided into 5 different grades, which were:

    1. No ischemia/necrosis was observed in NAC (Grade I).
    2. Transient ischemia recovered without necrosis (Grade II).
    3. Partial ischemia/necrosis, recovered without loss of nipple volume (Grade III).
    4. Partial NAC necrosis with partial volume loss of nipple (Grade IV).
    5. Total NAC necrosis with all volume loss of nipple (Grade V). NAC ischemia/necrosis was segregated into no NAC necrosis (Grade I-III) and NAC necrosis (Grade IV-V).

    The ischemia/necrosis of NAC between different R-NSM, C-NSM and E-NSM groups were recorded and compared.

    Measured: evaluated in post operative 2 weeks to 3 months post operation

  10. Rate of Surgical margin involvement in specimen pathologic examination

    Rate of Surgical margin involvement in specimen during pathologic examination, and surgical margin involvement was defined as tumor on the ink.

    Measured: post operative 2 weeks after pathologic report available

  11. Aesthetic outcome evaluation-Patient reported cosmetic outcome results

    • Post-operative aesthetic results will be evaluated by comparing pre-operative and post-operative results. A selfreported questionnaire to evaluate the cosmetic outcome of breast cancer patients with mastectomy following breast reconstruction was conducted 1-3 months after the operation. This questionnaire comprises of 10 questions based on 4 itemized scales, which will be graded as "1, dis-satisfied", "2, fair", "3, satisfied", and "4, very satisfied".

    Measured: 1-3 months after the operation when the wound was healed

  12. Blood loss during operation

    Blood loss (ml) during operation was compared between groups (R-NSM, C-NSM and R-NSM)

    Measured: immediate post operation

  13. Hospital stay

    Hospital stay (days) of patients receiving different operations (R-NSM, C-NSM, and E-NSM)

    Measured: within 2 weeks of operation

  14. Mean mastectomy weight

    Mean mastectomy weight (gm) of patients receiving different operations (R-NSM, C-NSM, and E-NSM)

    Measured: immediate post operation

  15. Reconstruction implant volume

    Reconstruction implant volume (ml) of patients receiving different operations (R-NSM, C-NSM, and E-NSM)

    Measured: immediate post operation

Secondary outcomes (3)

  1. Cost- analysis of C-NSM versus R-NSM or E-NSM

    The medical cost associated with robotic versus conventional or endoscopic assisted NSM will be collected and compared. The medical cost incurred for each procedure include overall hospital cost. Information on surgery related expenses will obtained from the finance department of the institution. In Taiwan, the operation fees of breast reconstruction and robotic breast surgery are not reimbursed by national insurance.

    The medical cost covered by national insurance include operations fee for breast cancer and/or axillary lymph node surgery, anesthesia, admission fee, and all other medical related expenses.

    • The medical cost not reimbursed by national insurance, and needed to be paid for by patients include fees for breast reconstruction, robotic breast surgery, endoscopic breast surgery, instruments and prosthetic implants.
    • Cost is expressed in New Taiwan dollars (NTDs) and in United States dollars (USDs). An exchange rate of 31 NTD/USD was used to convert NTD to USD.

    Measured: post operation one month

  2. Disease free Survival

    disease-free survival between R-NSM, C-NSM or E-NSM .

    Measured: 5 years post operation

  3. Overall survival

    overall survival between R-NSM, C-NSM or E-NSM .

    Measured: 5 years post operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2019
  2. Study start22 Aug 2019
  3. Primary completion31 Jul 2021 (estimated)
  4. Study completion31 Dec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Retrospective, multi-centers pooled data analysis of R-NSM versus C-NSM or E-NSM in the management of breast cancer. 3 arms study for comparisons
Masking
None (open label)
Enrolment
900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04049305
Sponsor's protocol ID
CCH-IRB-190414-R
Other IDs
MOST 108-2314-B-371-006-
Acronym
RCENSM-R
Status last verified
Jul 2020
First submitted
24 Jul 2019
Last updated
16 Jul 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Petit JY, Veronesi U, Luini A, Orecchia R, Rey PC, Martella S, Didier F, De Lorenzi F, Rietjens M, Garusi C, Sonzogni A, Galimberti V, Leida E, Lazzari R, Giraldo A. When mastectomy becomes inevitable: the nipple-sparing approach. Breast. 2005 Dec;14(6):527-31. doi: 10.1016/j.breast.2005.08.028. Epub 2005 Oct 12.

    PubMed 16226028

  • Sakamoto N, Fukuma E, Higa K, Ozaki S, Sakamoto M, Abe S, Kurihara T, Tozaki M. Early results of an endoscopic nipple-sparing mastectomy for breast cancer. Ann Surg Oncol. 2009 Dec;16(12):3406-13. doi: 10.1245/s10434-009-0661-8.

    PubMed 19662457

  • Tukenmez M, Ozden BC, Agcaoglu O, Kecer M, Ozmen V, Muslumanoglu M, Igci A. Videoendoscopic single-port nipple-sparing mastectomy and immediate reconstruction. J Laparoendosc Adv Surg Tech A. 2014 Feb;24(2):77-82. doi: 10.1089/lap.2013.0172. Epub 2014 Jan 8.

    PubMed 24401140

  • Toesca A, Peradze N, Galimberti V, Manconi A, Intra M, Gentilini O, Sances D, Negri D, Veronesi G, Rietjens M, Zurrida S, Luini A, Veronesi U, Veronesi P. Robotic Nipple-sparing Mastectomy and Immediate Breast Reconstruction With Implant: First Report of Surgical Technique. Ann Surg. 2017 Aug;266(2):e28-e30. doi: 10.1097/SLA.0000000000001397. No abstract available.

    PubMed 28692558

  • Moran MS, Schnitt SJ, Giuliano AE, Harris JR, Khan SA, Horton J, Klimberg S, Chavez-MacGregor M, Freedman G, Houssami N, Johnson PL, Morrow M. Society of Surgical Oncology-American Society for Radiation Oncology consensus guideline on margins for breast-conserving surgery with whole-breast irradiation in stages I and II invasive breast cancer. Ann Surg Oncol. 2014 Mar;21(3):704-16. doi: 10.1245/s10434-014-3481-4. Epub 2014 Feb 10.

    PubMed 24515565

  • Park SW, Lee TJ, Kim EK, Eom JS. Managing necrosis of the nipple-areola complex in breast reconstruction after nipple-sparing mastectomy: immediate nipple-areola complex reconstruction with banked skin. Plast Reconstr Surg. 2014 Jan;133(1):73e-74e. doi: 10.1097/01.prs.0000436805.58165.d3. No abstract available.

    PubMed 24374705

  • Leff DR, Vashisht R, Yongue G, Keshtgar M, Yang GZ, Darzi A. Endoscopic breast surgery: where are we now and what might the future hold for video-assisted breast surgery? Breast Cancer Res Treat. 2011 Feb;125(3):607-25. doi: 10.1007/s10549-010-1258-4. Epub 2010 Dec 3.

    PubMed 21128113

  • Lai HW, Chen ST, Chen DR, Chen SL, Chang TW, Kuo SJ, Kuo YL, Hung CS. Current Trends in and Indications for Endoscopy-Assisted Breast Surgery for Breast Cancer: Results from a Six-Year Study Conducted by the Taiwan Endoscopic Breast Surgery Cooperative Group. PLoS One. 2016 Mar 7;11(3):e0150310. doi: 10.1371/journal.pone.0150310. eCollection 2016.

    PubMed 26950469

  • Lai HW, Lin SL, Chen ST, Kuok KM, Chen SL, Lin YL, Chen DR, Kuo SJ. Single-Axillary-Incision Endoscopic-Assisted Hybrid Technique for Nipple-Sparing Mastectomy: Technique, Preliminary Results, and Patient-Reported Cosmetic Outcome from Preliminary 50 Procedures. Ann Surg Oncol. 2018 May;25(5):1340-1349. doi: 10.1245/s10434-018-6383-z. Epub 2018 Feb 26.

    PubMed 29484564

  • Toesca A, Peradze N, Manconi A, Galimberti V, Intra M, Colleoni M, Bonanni B, Curigliano G, Rietjens M, Viale G, Sacchini V, Veronesi P. Robotic nipple-sparing mastectomy for the treatment of breast cancer: Feasibility and safety study. Breast. 2017 Feb;31:51-56. doi: 10.1016/j.breast.2016.10.009. Epub 2016 Nov 2.

    PubMed 27810700

  • Sarfati B, Struk S, Leymarie N, Honart JF, Alkhashnam H, Tran de Fremicourt K, Conversano A, Rimareix F, Simon M, Michiels S, Kolb F. Robotic Prophylactic Nipple-Sparing Mastectomy with Immediate Prosthetic Breast Reconstruction: A Prospective Study. Ann Surg Oncol. 2018 Sep;25(9):2579-2586. doi: 10.1245/s10434-018-6555-x. Epub 2018 Jun 29.

    PubMed 29959612

  • Lai HW, Chen ST, Lin SL, Chen CJ, Lin YL, Pai SH, Chen DR, Kuo SJ. Robotic Nipple-Sparing Mastectomy and Immediate Breast Reconstruction with Gel Implant: Technique, Preliminary Results and Patient-Reported Cosmetic Outcome. Ann Surg Oncol. 2019 Jan;26(1):42-52. doi: 10.1245/s10434-018-6704-2. Epub 2018 Aug 14.

    PubMed 30109537

  • Lai HW, Wang CC, Lai YC, Chen CJ, Lin SL, Chen ST, Lin YJ, Chen DR, Kuo SJ. The learning curve of robotic nipple sparing mastectomy for breast cancer: An analysis of consecutive 39 procedures with cumulative sum plot. Eur J Surg Oncol. 2019 Feb;45(2):125-133. doi: 10.1016/j.ejso.2018.09.021. Epub 2018 Oct 17.

    PubMed 30360987

  • Lai HW, Huang RH, Wu YT, Chen CJ, Chen ST, Lin YJ, Chen DR, Lee CW, Wu HK, Lin HY, Kuo SJ. Clinicopathologic factors related to surgical margin involvement, reoperation, and residual cancer in primary operable breast cancer - An analysis of 2050 patients. Eur J Surg Oncol. 2018 Nov;44(11):1725-1735. doi: 10.1016/j.ejso.2018.07.056. Epub 2018 Aug 1.

    PubMed 30120037

Questions about this trial

What is this clinical trial studying?

A study testing Robotic assisted nipple sparing mastectomy (R-NSM), conventional nipple sparing mastectomy (C-NSM) and Endoscopic assisted nipple sparing mastectomy (E-NSM) in people with Breast Cancer Female, run by Changhua Christian Hospital at 13 sites in 3 countries.

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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Taiwan, Italy, South Korea. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hung-Wen Lai, MD, PhD (+886933496822, hwlai650420@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Operation time (time frame: immediate post operation). The study lists 15 primary outcomes in all. 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 NCT04049305, which also lists 14 linked publications.

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 16 Jul 2020.

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