新新药通
返回搜索
正在招募不适用编号 NCT07678866

A Preliminary Clinical Study Protocol for Evaluating the Efficacy and Safety of Pulse Electric Field Ablation Systems in Treating Adult Type 2 Diabetes Mellitus With Suboptimal Drug Control

报名条件（概要）

  • 年龄：18 Years – 70 Years
  • 性别：不限
  • 健康志愿者：不接受

完整入排标准请以官方页面为准。

开展国家/地区

China

研究药物 / 干预措施

见官方页面

申办方

Shanghai East Hospital

研究简介（原文）

experiment design: Single-center, single-arm, open-label trial Inclusion Criteria: 1. Ages 18-70. 2. At least 6 months prior to enrollment, the patient must have been diagnosed with type 2 diabetes mellitus. 3. The glycated hemoglobin level is 7.5%-10.5%. 4. BMI 2 7-40 kg/m2. 5. Patients who, within 12 weeks prior to screening, were treated with 2-3 oral hypoglycemic agents yet still had poorly controlled blood glucose levels, and could maintain the same medication regimen throughout the trial; or those whose blood glucose control was suboptimal despite lifestyle modifications. 6. Stable body weight (defined as a weight change of \<5% within 5 weeks prior to screening) 7. Donation of blood is prohibited during the trial participation period. 8. The subject must sign an Informed Consent Form (ICF), demonstrating their understanding of the purpose and procedures required for this study and their willingness to participate. 9. Be willing and able to comply with all requirements specified in the trial, including but not limited to completing the required assessments, adhering to the visit schedule, and complying with lifestyle restrictions. 10. Fertile female subjects must have a negative urine pregnancy test result during screening and must use contraception throughout the study period. Primary efficacy endpoint :HbA1c: The difference in HbA1c levels from the baseline period to 6 months post-treatment Observation period: 6 months postoperatively. Secondary efficacy endpoint HbA1c: The difference in HbA1c levels from the baseline period to after treatment Observation periods: 1 month, 3 months, and 12 months post-treatment. Average fasting blood glucose: The average fasting blood glucose level from the baseline period to after treatment Observation periods: 1 month, 3 months, 6 months, and 12 months post-treatment. Weight: Average weight from the baseline period to post-treatment Observation periods: 1 month, 3 months, 6 months, and 12 months post-treatment. Use of hypoglycemic agents: The incidence rate at which researchers determined the need for therapeutic intervention when glycated hemoglobin levels exceeded 8.5%. Observation periods: 1 month, 3 months, 6 months, and 12 months post-treatment. Safety Indicator 1. Adverse Events and Serious Adverse Events 2. Device defect 3. Intraoperative Instrument Performance Evaluation

适应症

Type 2 Diabetes Mellitus (T2DM)

主动联系研究团队

总联系人（申办方／研究总部）

中国／港澳台研究中心

问自己是否符合条件、如何预筛

我的病情档案

管理档案

档案只保存在您自己的浏览器里，不会上传，任何人（包括本站）都看不到。

英文版（发给研究团队）

Dear Study Team,

I am a patient in China and I am interested in participating in your clinical trial:

Study Title: A Preliminary Clinical Study Protocol for Evaluating the Efficacy and Safety of Pulse Electric Field Ablation Systems in Treating Adult Type 2 Diabetes Mellitus With Suboptimal Drug Control
ClinicalTrials.gov Identifier: NCT07678866
Sponsor: Shanghai East Hospital
Investigational product: N/A

About me:
- Age: (please fill in)
- Sex: (please fill in)
- Confirmed diagnosis and stage: (please fill in)
- Biomarkers / genetic testing: not available
- Prior and current treatments: (please fill in)
- Performance status (ECOG): not assessed
- Current location: China
- Travel ability: (please fill in)

Could you please let me know:
1. Whether I might be eligible for this study;
2. Which site would be closest and most practical for me, and whether remote pre-screening is possible;
3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening.

I can provide English translations of my medical records. Thank you very much for your time and help.

Kind regards,
(your name)
(your email / phone with country code)

中文对照（供您核对）

尊敬的研究团队：

我是一位来自中国的患者，希望咨询参加以下临床试验的可能：

研究名称：A Preliminary Clinical Study Protocol for Evaluating the Efficacy and Safety of Pulse Electric Field Ablation Systems in Treating Adult Type 2 Diabetes Mellitus With Suboptimal Drug Control
试验编号：NCT07678866
申办方：Shanghai East Hospital
研究药物：未公布

我的基本情况：
- 年龄：（请填写）
- 性别：（请填写）
- 确诊疾病与分期：（请填写）
- 基因／标志物检测：暂无
- 既往及当前治疗：（请填写）
- 体能状态（ECOG）：未评估
- 目前所在城市：中国
- 可前往范围：（请填写）

想请教三个问题：
1. 我是否可能符合本研究的入组标准？
2. 哪个中心对我最方便可行？能否远程预筛？
3. 预筛需要准备哪些资料（病历、病理、影像、近期化验）？

我可以提供英文翻译版病历。感谢您的时间与帮助。

顺祝安康
（您的姓名）
（您的邮箱／带国际区号的电话）
用邮件客户端发送给 lanzhong@tongji.edu.cn

提示：请与主治医生一起发信——由医生署名的申请，回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复，两周无回音可礼貌追问一次。

下一步怎么做？

  1. 把本页信息带给您的主治医生，评估是否适合参加。
  2. 点击下方按钮打开官方注册页，查看研究中心联系方式。
  3. 直接联系研究团队咨询报名事宜（通常有中文同声翻译服务可协助沟通）。
在 ClinicalTrials.gov 查看官方页面