PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic TNBC

March 9, 2025 updated by: Biotheus Inc.

A Multicenter, Randomized, Double-blind Phase III Study of PM8002 or Placebo in Combination With Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic Triple-negative Breast Cancer(TNBC)

This multicenter, randomized, double-blind study will evaluate the safety and efficacy of PM8002 in combination with Nab-Paclitaxel compared with placebo combined with Nab-Paclitaxel as first-line treatment in inoperable locally advanced/metastatic triple-negative breast cancer(TNBC)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

360

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Bengbu, Anhui, China
        • Recruiting
        • The First Affiliated Hospital of Bengbu Medical University
        • Principal Investigator:
          • Gongsheng Jin
        • Contact:
          • Gongsheng Jin
      • Hefei, Anhui, China
        • Recruiting
        • The First Affiliated Hospital of Anhui Medical University
        • Contact:
          • Yingying Du
        • Principal Investigator:
          • Yingying Du
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Principal Investigator:
          • Peng Yuan
        • Contact:
          • Peng Yuan
      • Beijing, Beijing, China
        • Recruiting
        • Fifth Medical Center of Chinese PLA General Hospital
        • Contact:
          • Tao Wang
        • Principal Investigator:
          • Tao Wang
    • Chongqing
      • Chongqing, Chongqing, China
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
          • Lu Gan
        • Principal Investigator:
          • Lu Gan
      • Chongqing, Chongqing, China
        • Recruiting
        • Chongqing University Cancer Hospital
        • Contact:
          • Xiaohua Zeng
        • Principal Investigator:
          • Xiaohua Zeng
      • Chongqing, Chongqing, China
        • Recruiting
        • The Southwest Hospital of Army Medical University
        • Contact:
          • Yi Zhang
        • Principal Investigator:
          • Yi Zhang
    • Fujian
      • Fuzhou, Fujian, China
        • Recruiting
        • Fujian Provincial Cancer Hospital
        • Contact:
          • Fan Wu
        • Principal Investigator:
          • Fan Wu
    • Gansu
      • Lanzhou, Gansu, China
        • Recruiting
        • Lanzhou University First Hospital
        • Contact:
          • Xiaoling Ling
        • Principal Investigator:
          • Xiaoling Ling
    • Guangdong
      • Foshan, Guangdong, China
        • Recruiting
        • The First People's Hospital of Foshan
        • Contact:
          • Qian Hu
        • Principal Investigator:
          • Qian Hu
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun yat-sen University Cancer Center
        • Contact:
          • Shusen Wang
        • Principal Investigator:
          • Shusen Wang
      • Guangzhou, Guangdong, China
        • Recruiting
        • Affillated Cancer Hospital and Institute of Guangzhou Medical University
        • Contact:
          • Hongsheng Li
        • Principal Investigator:
          • Hongsheng Li
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun Yat-sen Memorial Hospital Affiliated to Sun Yat-sen University
        • Contact:
          • Ying Wang
        • Principal Investigator:
          • Ying Wang
        • Principal Investigator:
          • Yaping Yang
      • Shaoguan, Guangdong, China
        • Recruiting
        • Yuebei People's Hospital
        • Contact:
          • Ruiwen Lei
        • Principal Investigator:
          • Ruiwen Lei
    • Guangxi
      • Nanning, Guangxi, China
        • Recruiting
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
          • Yang Li
        • Principal Investigator:
          • Yang Li
      • Nanning, Guangxi, China
        • Recruiting
        • Guangxi Medical University Cancer Hospital
        • Contact:
          • Weimin Xie
        • Principal Investigator:
          • Weimin Xie
    • Hebei
      • Baoding, Hebei, China
        • Recruiting
        • Affiliated Hospital of Hebei University
        • Contact:
          • Hua Yang
        • Principal Investigator:
          • Hua Yang
      • Shijiazhuang, Hebei, China
        • Recruiting
        • The Fourth Hospital of Hebei Medical University
        • Contact:
          • Cuizhi Geng
        • Principal Investigator:
          • Cuizhi Geng
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Recruiting
        • Harbin Medical University Cancer Hospital
        • Principal Investigator:
          • Qingyuan Zhang
        • Contact:
          • Qingyuan Zhang
    • Henan
      • Anyang, Henan, China
        • Recruiting
        • The Affiliated Anyang Tumor Hospital of Henan University of Science and Technology
        • Contact:
          • Junlan Guo
        • Principal Investigator:
          • Junlan Guo
      • Luoyang, Henan, China
        • Recruiting
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Principal Investigator:
          • Xinshuai Wang
        • Contact:
          • Xinshuai Wang
      • Nanyang, Henan, China
        • Recruiting
        • Nanyang Central Hospital
        • Principal Investigator:
          • Hao Zhang
        • Contact:
          • Hao Zhang
      • Xinxiang, Henan, China
        • Recruiting
        • The First Affiliated Hospital of Xinxiang Medical University
        • Contact:
          • Yinghua Ji
        • Principal Investigator:
          • Yinghua Ji
      • Zhengzhou, Henan, China
        • Recruiting
        • Henan Cancer Hospital
        • Principal Investigator:
          • Min Yan
        • Contact:
          • Min Yan
      • Zhengzhou, Henan, China
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Principal Investigator:
          • Hong Zong
        • Contact:
          • Hong Zong
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Zhongnan Hospital of Wuhan University
        • Contact:
          • Haijun Yu
        • Principal Investigator:
          • Haijun Yu
      • Wuhan, Hubei, China
        • Recruiting
        • Hubei Cancer Hospital
        • Principal Investigator:
          • Xinhong Wu
        • Contact:
          • Xinhong Wu
      • Wuhan, Hubei, China
        • Recruiting
        • Union Hospital Tongji Medical College of HUST
        • Contact:
          • Jing Yao
        • Principal Investigator:
          • Jing Yao
    • Hunan
      • Changde, Hunan, China
        • Recruiting
        • The First People's Hospital of Changde City
        • Contact:
          • Tao Wu
        • Principal Investigator:
          • Tao Wu
      • Changsha, Hunan, China
        • Recruiting
        • Hunan Cancer Hospital
        • Principal Investigator:
          • Quchang Ouyang
        • Contact:
          • Quchang Ouyang
      • Xiangyang, Hunan, China
        • Recruiting
        • Xiangyang Cancer Hospital
        • Contact:
          • Yuehua Wang
        • Principal Investigator:
          • Yuehua Wang
      • Yongzhou, Hunan, China
        • Recruiting
        • The Central Hospital of Yongzhou
        • Contact:
          • Sijuan Ding
        • Principal Investigator:
          • Sijuan Ding
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Not yet recruiting
        • Jiangsu Province Hospital
        • Contact:
          • Yongmei Yin
        • Principal Investigator:
          • Yongmei Yin
      • Nantong, Jiangsu, China
        • Recruiting
        • The Affiliated Hospital of Nantong University
        • Contact:
          • Sujie Ni
        • Principal Investigator:
          • Sujie Ni
      • Suzhou, Jiangsu, China
        • Recruiting
        • The Second Affiliated Hospital of Suzhou University
        • Principal Investigator:
          • Zhixiang Zhuang
        • Contact:
          • Zhixiang Zhuang
      • Xuzhou, Jiangsu, China
        • Recruiting
        • Xuzhou Central Hospital
        • Contact:
          • Yanhua Liu
        • Principal Investigator:
          • Yanhua Liu
      • Yangzhou, Jiangsu, China
        • Recruiting
        • Northern Jiangsu People's Hospital
        • Contact:
          • Deyuan Fu
        • Principal Investigator:
          • Deyuan Fu
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Recruiting
        • Jiangxi Cancer Hospital
        • Contact:
          • Zhengkui Sun
        • Principal Investigator:
          • Zhengkui Sun
    • Jilin
      • Changchun, Jilin, China
        • Recruiting
        • The First Hospital of Jilin University
        • Principal Investigator:
          • Jiuwei Cui
        • Contact:
          • Yanqing Cao
      • Changchun, Jilin, China
        • Recruiting
        • Jilin Cancer Hospital
        • Contact:
          • Chunjiao Wu
        • Principal Investigator:
          • Chunjiao Wu
    • Liaoning
      • Dalian, Liaoning, China
        • Recruiting
        • The Second Hospital of Dalian Medical University
        • Contact:
          • man Li
        • Principal Investigator:
          • Man Li
      • Dalian, Liaoning, China
        • Recruiting
        • Affiliated Zhongshan Hospital of Dalian University
        • Contact:
          • Xuening Ji
        • Principal Investigator:
          • Xuening Ji
      • Shenyang, Liaoning, China
        • Recruiting
        • The First Hospital of China Medical University
        • Contact:
          • Yuee Teng
      • Shenyang, Liaoning, China
        • Recruiting
        • Shengjing Hospital of China Medical University
        • Contact:
          • Caigang Liu
        • Principal Investigator:
          • Caigang Liu
      • Shenyang, Liaoning, China
        • Recruiting
        • Liaoning Cancer Hospital
        • Contact:
          • Jianyi Li
        • Principal Investigator:
          • Jianyi Li
    • Shaanxi
      • Xi'an, Shaanxi, China
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Principal Investigator:
          • Jin Yang
        • Contact:
          • Jin Yang
      • Xi'an, Shaanxi, China
        • Recruiting
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
          • Shuqun Zhang
        • Principal Investigator:
          • Shuqun Zhang
    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • Shandong Cancer Hospital
        • Contact:
          • Huihui Li
        • Principal Investigator:
          • Huihui Li
      • Jining, Shandong, China
        • Recruiting
        • Affiliated Hospital of Jining Medical University
        • Contact:
          • Zhongsheng Xia
        • Principal Investigator:
          • Zhongsheng Xia
      • Linyi, Shandong, China
        • Recruiting
        • Linyi Cancer Hospital
        • Contact:
          • Jingfen Wang
        • Principal Investigator:
          • Jingfen Wang
      • Qingdao, Shandong, China
        • Recruiting
        • The Affiliated Hospital of Qingdao University
        • Principal Investigator:
          • Haibo Wang
        • Contact:
          • Haibo Wang
      • Weifang, Shandong, China
        • Recruiting
        • Weifang People's Hospital
        • Contact:
          • Wenhui Wang
        • Principal Investigator:
          • Wenhui Wang
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Principal Investigator:
          • Jian Zhang
        • Principal Investigator:
          • Jiong Wu
        • Contact:
          • Jian Zhang
      • Shanghai, Shanghai, China
        • Recruiting
        • Obstetrics and Gynecology Hospital of Fudan University
        • Contact:
          • Kejin Wu
        • Principal Investigator:
          • Kejin Wu
      • Shanghai, Shanghai, China
        • Recruiting
        • Ruijin Hospital of Shanghai Jiao Tong University School of Medicine
        • Contact:
          • Kunwei Shen
        • Principal Investigator:
          • Kunwei Shen
    • Shanxi
      • Taiyuan, Shanxi, China
        • Recruiting
        • Shanxi Cancer Hospital
        • Contact:
          • Fuguo Tian
        • Principal Investigator:
          • Fuguo Tian
      • Yuncheng, Shanxi, China
        • Recruiting
        • Runcheng City Center Hospital
        • Contact:
          • Xiaoke Hou
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • Sichuan Cancer Hospital
        • Contact:
          • Junjie Li
        • Principal Investigator:
          • Junjie Li
      • Chengdu, Sichuan, China
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
          • Jing Luo
        • Principal Investigator:
          • Jing Luo
      • Mianyang, Sichuan, China
        • Recruiting
        • Mianyang Central Hospital
        • Contact:
          • Xiaobo Du
        • Principal Investigator:
          • Xiaobo Du
      • Nanchong, Sichuan, China
        • Recruiting
        • Nanchong Central Hospital of Sichuan Province
        • Principal Investigator:
          • Xin Hu
        • Contact:
          • Xin Hu
      • Neijiang, Sichuan, China
        • Recruiting
        • The Second People's Hospital of Neijiang
        • Contact:
          • Xujiang Wang
        • Principal Investigator:
          • Xujiang Wang
      • Neijiang, Sichuan, China
        • Recruiting
        • The First People's Hospital of Neijiang
        • Contact:
          • Shubin Tang
        • Principal Investigator:
          • Shubin Tang
      • Suining, Sichuan, China
        • Recruiting
        • Suining Central Hospital
        • Contact:
          • Hongwei Yang
        • Principal Investigator:
          • Hongwei Yang
    • Tianjin
      • Tianjin, Tianjin, China
        • Recruiting
        • Tian Jin Medicial University Cancer Institute&Hospital
        • Principal Investigator:
          • Zhongsheng Tong
        • Contact:
          • Zhongsheng Tong
    • Yunnan
      • Kunming, Yunnan, China
        • Recruiting
        • Yunnan Cancer Hospital (The Third Affiliated Hospital of Kunming Medical University)
        • Contact:
          • Jianyun Nie
        • Principal Investigator:
          • Jianyun Nie
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Zhejiang Cancer Hospital
        • Principal Investigator:
          • Hai Hu
        • Contact:
          • Hai Hu
      • Hangzhou, Zhejiang, China
        • Recruiting
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Principal Investigator:
          • Yiding Chen
        • Contact:
          • Yiding Chen
      • Taizhou, Zhejiang, China
        • Recruiting
        • Taizhou Hospital of Zhejiang Province
        • Contact:
          • Bojian Xie
        • Principal Investigator:
          • Bojian Xie
      • Wenzhou, Zhejiang, China
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
          • Zhenchen Wang
        • Principal Investigator:
          • Zhenchen Wang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Ability to understand and willing to provide written informed consent and to comply with scheduled visits and study procedures;
  • Female, aged 18 to 70 years (inclusive);
  • Histologically confirmed unresectable locally advanced or metastatic breast cancer with negative status for ER, PR, and HER-2. Testing results for all three markers conducted within 24 months prior to the initiation of the study by a local facility accredited by clinical research center are acceptable. If deemed necessary by the investigator during screening, subjects may provide additional biopsy to confirm the latest pathological;
  • Subjects who have not received prior systemic treatment（except endocrine therapy） for advanced breast cancer are eligible for the study. Subjects who have received Taxane-based chemotherapy during the neoadjuvant and/or adjuvant treatment phase are eligible, as long as the occurrence of relapse or metastasis is at least 12 months after the end of treatment;
  • Performance status as assessed by the Eastern Cooperative Oncology Group (ECOG) is 0-1;
  • Life expectancy of 12 weeks or more;
  • According to RECIST 1.1, the subject has at least 1 measurable lesion as the targeted lesion (the only bone metastasis or the only central nervous system metastasis should not be considered as a measurable lesion. A measurable lesion located at the previously irradiated radiation field or other local treatment area should not be selected as targeted lesion, unless the lesion shows unequivocal radiographic progression).

Exclusion Criteria:

  • Previous treatment with immune checkpoint agonists (such as CD137 agonists) or immune checkpoint inhibitors (such as CTLA-4, PD-1, PD-L1, LAG3 monoclonal antibody, etc.) or anti-vascular endothelial growth factor (VEGF) target drugs;
  • Has uncontrolled or symptomatic brain or spine cord metastases;
  • Those who have had other active malignant tumors within 5 years prior to the study treatment, except for those that can be treated locally and have been cured ;
  • Poorly controlled hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg);
  • With a history of hypertensive crisis or hypertensive encephalopathy;
  • With a history of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess within the last 6 months prior to the start of the study treatment;
  • Adverse events resulting from prior anti-tumor therapies should be assessed and graded according to the CTCAE 5.0 criteria, subjects whose AEs have not returned to Grade 1 or below;
  • Has uncontrollable pleural, pericardial, or abdominal effusions;
  • Has received allogeneic hematopoietic stem cell transplantation or organ transplantation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PM8002 Plus Nab-Paclitaxel
Patients will receive both PM8002 and Nab-Paclitaxel.
Drug: PM8002
PM8002 20 mg/kg via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle
Drug: Nab-Paclitaxel
Nab-Paclitaxel 100mg/m2 via IV infusion on Days 1, 8, and 15 of each 28-day cycle
Placebo Comparator: Placebo Plus Nab-Paclitaxel
Patients will receive both Placebo and Nab-Paclitaxel.
Drug: Nab-Paclitaxel
Nab-Paclitaxel 100mg/m2 via IV infusion on Days 1, 8, and 15 of each 28-day cycle
Drug: Placebo
Placebo 20 mg/kg via IV infusion on Days 1 and 15 of each 28-day cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS) assessed by Blinded Independent Review Committee (BIRC)
Time Frame: Up to approximately 37 months from first patient in
Progression-free survival is defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on assessments by Blinded Independent Review Committee (BIRC) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.
Up to approximately 37 months from first patient in
Overall Survival (OS)
Time Frame: Up to approximately 37 months from first patient in
Overall survival is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis are censored at the date of the last follow-up.
Up to approximately 37 months from first patient in

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR) assessed by BIRC or investigators
Time Frame: Up to approximately 37 months from first patient in
ORR is defined as the percentage of participants in the analysis population who have a complete response (CR: disappearance of all lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experienced a CR or PR as assessed by BIRC or investigators based on RECIST 1.1 is presented.
Up to approximately 37 months from first patient in
Duration of response (DoR) assessed by BIRC or investigators
Time Frame: Up to approximately 37 months from first patient in
DoR is defined as the time period from the date of initial CR or PR until the date of PD or death due to any cause, whichever occurs first.
Up to approximately 37 months from first patient in
Incidence and severity of Adverse Event (AE) according to CTCAE 5.0
Time Frame: Up to 30 days after last treatment
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Up to 30 days after last treatment
Disease control rate (DCR) assessed by BIRC or investigators
Time Frame: Up to approximately 37 months from first patient in
DCR is defined as the sum rate of CR, PR and Stable Disease (SD), as determined by BIRC or investigators using RECIST v1.1
Up to approximately 37 months from first patient in
Differences in the scores of health-related quality of life (HRQol) evaluated by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30)
Time Frame: Up to 30 days after last treatment
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" (Item 29) and "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores were standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score are presented.
Up to 30 days after last treatment
Differences in the scores of health-related quality of life (HRQol) evaluated by EORTC Quality of Life Questionnaire - Breast Cancer (QLQ-BR42)
Time Frame: Up to 30 days after last treatment
Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score denotes worse symptoms for the systemic therapy side effects symptom scale.
Up to 30 days after last treatment
PFS assessed by investigator
Time Frame: Up to approximately 37 months from first patient in
Progression-free survival is defined as the time from randomization to the first documented PD per RECIST 1.1 based on assessments by investigator or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.
Up to approximately 37 months from first patient in

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotheus Inc.

Investigators

  • Study Chair: Jiong Wu, professor, Fudan University
  • Study Chair: Jian Zhang, professor, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2024

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

May 14, 2024

First Submitted That Met QC Criteria

May 14, 2024

First Posted (Actual)

May 17, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 9, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PM8002-C013C-TNBC-R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be published or presented for publications (poster, abstract,articles or papers) or any presentations.

IPD Sharing Time Frame

After the trial completed

IPD Sharing Access Criteria

NCI is committed to sharing data in accordance with NIH policy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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