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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

NCT07678866 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2026-07-01

No results posted yet for this study

Summary

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

Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Sponsors & Collaborators

  • Shanghai East Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2028-01-31
Completion
2028-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07678866 on ClinicalTrials.gov