Efficacy of HIPEC in Patients With Colorectal Cancer at High Risk of Peritoneal Carcinomatosis

June 15, 2020 updated by: Affiliated Cancer Hospital & Institute of Guangzhou Medical University

A Multicenter Prospective Randomized Controlled Clinical Trial of Hyperthermic Intraperitoneal Chemotherapy After Colectomy in Patients With Colorectal Cancer at High Risk of Peritoneal Carcinomatosis

The purpose of this study is to determine the efficacy of adjuvant HIPEC with Mitomycin C after colectomy in the treatment of colorectal cancer patients at high risk of peritoneal carcinomatosis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The effectiveness of cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (HIPEC) have been addressed for the treatment of peritoneal carcinomatosis in selected patients. However, prophylactic HIPEC in colorectal cancer patients at high risk of metachronous peritoneal metastases remained controversial. In this study, patients with colorectal cancer cT4N0-2M0(AJCC/UICC staging system 8th edition) and planed to undergo intentionally colectomy (laparotomy, laparoscopy，or robotic ) are randomized into HIPEC group and control group. In HIPEC group, closed HIPEC is performed with Mitomycin C(30mg/m2) at 43 °C for 90 minutes, simultaneously or within 2 days after colectomy and followed by systemic chemotherapy. For the patients in the control group, systemic chemotherapy were administered after colectomy. The primary endpoint is peritoneal recurrence-free survival (pRFS) rate. Secondary end points include overall survival (OS) rate, disease free survival (DFS) rate, liver metastatic rate, toxic effects, quality of life scores. All efficacy analyses are conducted in the intention-to-treat population, per-protocol population and pT4 subgroups due to pathologic tumor invasion can not be acquired before HIPEC. Safety analysis include only patients who receive their randomly assigned treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
688

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Tianpei Guan, MD
  • Phone Number: 086-13660895051
  • Email: dr_guan@126.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100044
        • Not yet recruiting
        • Peking University People's Hospital
        • Contact:
        • Principal Investigator:
          • Bin Liang, MD
        • Sub-Investigator:
          • Chao Wang, MD
      • Beijing, Beijing, China
        • Not yet recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Contact:
        • Principal Investigator:
          • Xishan Wang, MD
        • Sub-Investigator:
          • Wei Pei, MD
      • Beijing, Beijing, China
        • Not yet recruiting
        • Beijing Hospital
        • Contact:
        • Principal Investigator:
          • Gang Zhao, MM
        • Sub-Investigator:
          • Hua Yang, MM
      • Beijing, Beijing, China
        • Not yet recruiting
        • Peking University Cancer Hospital & Institute
        • Contact:
          • Aiwen Wu, MD
          • Phone Number: 086-13911577190
          • Email: wuaw@sina.com
        • Sub-Investigator:
          • Qiushi Dong, MM
    • Chongqing
      • Chongqing, Chongqing, China
        • Not yet recruiting
        • Chongqing Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Hao Sun, MD
        • Sub-Investigator:
          • Miao He, MD
      • Chongqing, Chongqing, China
        • Not yet recruiting
        • First Affiliated Hospital of Chongqing Medical University
        • Contact:
        • Sub-Investigator:
          • Zhengqiang Wei, MD
      • Chongqing, Chongqing, China
        • Not yet recruiting
        • Second Affiliated Hospital of Chongqing Medical University
        • Contact:
        • Principal Investigator:
          • Jijian Wang, MD
    • Guangdong
      • Foshan, Guangdong, China
        • Not yet recruiting
        • The First People's Hospital of FoShan (Affiliated FoShan Hospital of Sun Yat-sen University)
        • Contact:
        • Principal Investigator:
          • Longqing Cheng, MM
        • Sub-Investigator:
          • Yan-an Gao, MM
      • Guangzhou, Guangdong, China, 510060
        • Not yet recruiting
        • Sun Yat-Sen University Cancer Center
        • Contact:
        • Principal Investigator:
          • Zhizhong Pan, MD
        • Sub-Investigator:
          • Fulong Wang, MD
      • Guangzhou, Guangdong, China, 510515
        • Not yet recruiting
        • Nanfang Hospital of Southern Medical University
        • Contact:
        • Principal Investigator:
          • Haijun Deng, MD
        • Sub-Investigator:
          • Kai Sun, MD
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • The First Affiliated Hospital, Sun Yat-sen University
        • Contact:
        • Principal Investigator:
          • Chuangqi Chen, MD
        • Sub-Investigator:
          • Jianhui Chen, MD
      • Guangzhou, Guangdong, China, 510080
        • Not yet recruiting
        • Guangdong Provincal People's Hospital
        • Contact:
        • Contact:
          • M.M
        • Sub-Investigator:
          • ZeJian Lv, MM
      • Guangzhou, Guangdong, China, 510095
        • Recruiting
        • Affiliated Cancer Hospital & Institute of Guangzhou Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shuzhong Cui, MD
        • Sub-Investigator:
          • Tianpei Guan, MD
      • Guangzhou, Guangdong, China, 510120
        • Not yet recruiting
        • Guangdong Provincial Hospital of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
        • Principal Investigator:
          • Wei Wang, MD
        • Contact:
        • Sub-Investigator:
          • WenJun Xiong, MD
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • The Six Affiliated Hospital,Sun Yat-sen University
        • Contact:
        • Sub-Investigator:
          • Wei Chen, MD
      • Jiangmen, Guangdong, China
        • Not yet recruiting
        • JiangMen Central Hospital Affiliated JiangMen Hospital Of SUN YAT-SEN University
        • Contact:
        • Principal Investigator:
          • Chao Li, BD
        • Sub-Investigator:
          • Wenchuan Jiang, MM
      • Meizhou, Guangdong, China
        • Recruiting
        • Meizhou People's Hospital
        • Contact:
        • Principal Investigator:
          • Zuguang Zuguang, MM
        • Sub-Investigator:
          • Haijing Zeng, MM
      • Shantou, Guangdong, China
        • Not yet recruiting
        • Affiliated Shantou Hospital of Sun Yat-sen University
        • Contact:
        • Principal Investigator:
          • Xiaozhong Wang, MM
        • Sub-Investigator:
          • Chufa Zheng, MM
      • Shenzhen, Guangdong, China
        • Not yet recruiting
        • Shenzhen Second People's Hospital
        • Contact:
        • Principal Investigator:
          • Haitao Zhang, MM
        • Sub-Investigator:
          • Yuanzhi Tang, MM
      • Zhongshan, Guangdong, China
        • Not yet recruiting
        • Zhongshan City People's Hospital
        • Contact:
        • Principal Investigator:
          • Yao Wang, MD
        • Sub-Investigator:
          • Kai Li, MM
      • Zhuhai, Guangdong, China
        • Not yet recruiting
        • Zhuhai People's Hospital, Zhuhai hospital affiliated with Jinan University
        • Contact:
        • Principal Investigator:
          • Hui Liang, BD
        • Sub-Investigator:
          • Yaoming Huang, MM
    • Guangxi Zhuang Autonomous Region
      • Nanning, Guangxi Zhuang Autonomous Region, China
        • Not yet recruiting
        • People's Hospital of Guangxi Zhuang Autonomous Region
        • Contact:
        • Principal Investigator:
          • Wei Mai, BS
        • Sub-Investigator:
          • Lei Li, MD
        • Sub-Investigator:
          • Xiaotong Wang, MD
      • Nanning, Guangxi Zhuang Autonomous Region, China
        • Not yet recruiting
        • The Affiliated Tumor Hospital of Guangxi Medical University
        • Principal Investigator:
          • Jiansi Chen
        • Contact:
          • Jiansi Chen
    • Hebei
      • Shijiazhuang, Hebei, China
        • Not yet recruiting
        • Hebei Medical University Fourth Hospital
        • Contact:
        • Principal Investigator:
          • Bin Yu, MM
        • Sub-Investigator:
          • Zhenya Zhang, MD
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Union Hospital,Tongji Medical College, Huazhong Uninersity of Science and Technolgy
        • Contact:
        • Principal Investigator:
          • Kaixiong Tao, MD
        • Sub-Investigator:
          • Chuanqing Wu, MD
      • Wuhan, Hubei, China
        • Not yet recruiting
        • Wuhan University Renmin Hospital
        • Contact:
        • Principal Investigator:
          • Yongbin Zheng, MD
        • Sub-Investigator:
          • Chao Yang, MD
      • Wuhan, Hubei, China
        • Not yet recruiting
        • Zhongnan Hospital of Wuhan University
        • Contact:
        • Principal Investigator:
          • Congqing Jiang, MD
        • Principal Investigator:
          • Qun Qian, MD
    • Jiangsu
      • Xuzhou, Jiangsu, China
        • Not yet recruiting
        • The Affiliated Hospital of Xuzhou Medical University
        • Contact:
          • Jun Song, MD
          • Phone Number: 15105200058
        • Principal Investigator:
          • Jun Song, MD
        • Sub-Investigator:
          • Haixiao Fu, MM
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Not yet recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
        • Principal Investigator:
          • Zhigang Jie, MD
        • Sub-Investigator:
          • Tao Xiao, MD
    • Shanghai
      • Shanghai, Shanghai, China
        • Not yet recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
    • Sichuan
      • Chendu, Sichuan, China
        • Not yet recruiting
        • West China Hospital，Sichuan University
        • Principal Investigator:
          • Ziqiang Wang, MD
        • Contact:
        • Sub-Investigator:
          • Xiangbing Deng, MD
      • Chengdu, Sichuan, China, 610072
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
        • Principal Investigator:
          • Minghui Pang, MD
      • Chengdu, Sichuan, China
        • Not yet recruiting
        • The Third Peoples' Hospital of Chengdu
        • Contact:
        • Principal Investigator:
          • Yanjun Liu, MD
        • Sub-Investigator:
          • Yuanchuan Zhang, MD
      • Deyang, Sichuan, China
        • Not yet recruiting
        • People's Hospital of Deyang City
        • Contact:
        • Principal Investigator:
          • Gang Mai, MD
        • Sub-Investigator:
          • Zhen Liu, MD
      • Leshan, Sichuan, China
        • Not yet recruiting
        • Leshan People's Hospital
        • Contact:
        • Principal Investigator:
          • Jian Wang, BD
      • Luzhou, Sichuan, China
        • Not yet recruiting
        • The Affiliated Hospital of Southwest Medical University
        • Contact:
        • Principal Investigator:
          • Liang Xu, MM
        • Sub-Investigator:
          • Hui Yao, MD
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Not yet recruiting
        • The Second Affiliated Hospital,Zhejiang University School of Medicine
        • Contact:
        • Principal Investigator:
          • Kefeng Ding, MD
        • Sub-Investigator:
          • Lifeng Sun, MD

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 18 and 70 years
  • Nonpregnant or breast-feeding women
  • ECOG status 0-1
  • Colorectal adenocarcinoma or mucinous adenocarcinoma;
  • Intraoperative confirmed cT4N0-2M0 Colorectal cancer (visual determination - according to AJCC 8th edition) without previous anti-cancer treatment and R0 resection could be achieved
  • Laboratory tests within 2 weeks before Randomization：Neutrophil ≥ 2.0 /mm3, , platelets ≥ 100,000/mm3, hemoglobin≥90g/l, Alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 ×ULN), total bilirubin(TBIL)≤ 1.5 × ULN, serum creatinine ≤ 1.5 ×ULN
  • Written informed consent

Exclusion Criteria:

  • Rectal cancer below peritoneal reflection
  • Concurrent with or have other cancer within the past 5 years ( except for skin basal cell carcinoma, or cervical carcinoma in situ, who have received radical treatment)
  • Severe abdominal infection or extensive fibrosis of peritoneal cavity that lead to impossible separation
  • Surgical procedures conversion(from robotic or laparoscopic surgery to laparotomy) or emergency surgery due to perforation or obstruction
  • Existence of distance metastasis during surgery (M1) or can not achieve R0 resection
  • Contraindiction of mitomycin c(chickenpox or shingles)
  • Poorly controlled respiratory or cardiac disease, severe hepatic or renal dysfunction,drug abuse or uncontrolled mental disease

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: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Matched control
Patients undergo radical resection of primary colorectal cancer and receive standard adjuvant systemic chemotherapy
Procedure: Radical colectomy
Patients undergo radical resection of the primary colorectal cancer(open or laparoscopic/robotic)
Drug: Systemic chemotherapy

Systemic chemotherapy regimens: CapeOx and mFOLFOX6 are preferred for stage Ⅲ patients.

CapeOx:oxaliplatin 130 mg/m2 IV d1 + capecitabine 1000mg/m2 po bid d1-14. Repeat every three weeks for eight cycles.

mFOLFOX6:oxaliplatin 85 mg/m2 IV d1 + leucovorin calcium 400 mg/m2 IV d1 + 5-FU 400 mg/m2 IV bolus d1 + 5-FU 2400 mg/m2 continuous IV over 46-48 hours d1-2. Repeat every two weeks for twelve cycles.

For stageⅡpatiens, regimens recommend by NCCN guide line(2019 v1) are acceptable.
Experimental: HIPEC
Patients undergo radical resection of colorectal cancer and HIPEC simultaneously or within 2 days after primary tumor resection. Followed by standard adjuvant systemic chemotherapy
Procedure: Radical colectomy
Patients undergo radical resection of the primary colorectal cancer(open or laparoscopic/robotic)
Drug: Systemic chemotherapy

Systemic chemotherapy regimens: CapeOx and mFOLFOX6 are preferred for stage Ⅲ patients.

CapeOx:oxaliplatin 130 mg/m2 IV d1 + capecitabine 1000mg/m2 po bid d1-14. Repeat every three weeks for eight cycles.

mFOLFOX6:oxaliplatin 85 mg/m2 IV d1 + leucovorin calcium 400 mg/m2 IV d1 + 5-FU 400 mg/m2 IV bolus d1 + 5-FU 2400 mg/m2 continuous IV over 46-48 hours d1-2. Repeat every two weeks for twelve cycles.

For stageⅡpatiens, regimens recommend by NCCN guide line(2019 v1) are acceptable.

Procedure: HIPEC
HIPEC(simultaneously or within 2days after resection) with mitomycin c (30 mg/m2) at 43°C for 90 minutes.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Peritoneal recurrence free survival
Time Frame: 3-year
Peritoneal recurrence free survival is calculated from the date of randomization to the date of record peritoneal recurrence(with or without other metastasis), ovarian metastasis, malignant ascites, or death from any cause, whichever occurred first.
3-year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Disease free survival
Time Frame: 3-year
Disease free survival is calculated from randomization to to the date of a first relapse, the diagnosis of a secondary colorectal cancer after the initial diagnosis, or death from any cause, whichever occurred first.
3-year
Overall survival
Time Frame: 5-year
Overall survival is calculated from randomization to death from any cause.
5-year
Liver metastatic rate
Time Frame: 3-year
Liver metastatic rate is calculated from randomization to to the date of liver metastasis with or without other organ metastasis.
3-year
Number of participants with adverse events
Time Frame: Up to 1 month after the last chemotherapy cycle
Incidence of acute and late toxicity
Up to 1 month after the last chemotherapy cycle

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The First Affiliated Hospital of Nanchang University
Chongqing University Cancer Hospital
Guangdong Provincial Hospital of Traditional Chinese Medicine
Wuhan University
Peking University People's Hospital
Sun Yat-sen University
Fudan University
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
First Affiliated Hospital, Sun Yat-Sen University
West China Hospital
Peking University Cancer Hospital & Institute
Second Affiliated Hospital, School of Medicine, Zhejiang University
Nanfang Hospital of Southern Medical University
Beijing Hospital
Guangdong Provincial People's Hospital
Sixth Affiliated Hospital, Sun Yat-sen University
Wuhan Union Hospital, China
Hebei Medical University Fourth Hospital
Renmin Hospital of Wuhan University
First People's Hospital of Foshan
The Second Affiliated Hospital of Chongqing Medical University
Shenzhen Second People's Hospital
Shantou Central Hospital
Sichuan Provincial People's Hospital
First Affiliated Hospital of Chongqing Medical University
The Affiliated Hospital of Xuzhou Medical University
Zhongshan People's Hospital, Guangdong, China
People's Hospital of Guangxi
The Affiliated Hospital Of Southwest Medical University
ZhuHai Hospital
Jiangmen Central Hospital
Meizhou People's Hospital
The People's Hospital of Leshan
The Third People's Hospital of Chengdu
People's Hospital of Deyang City
The Affiliated Tumor Hospital of Guangxi Medical 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 4, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HIPEC-06

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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