Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07315893
Brief Summary:
The objective of this clinical study is to assess the safety of the Su2ura® GI system when used for endoscopic suturing and soft-tissue approximation in patients referred for endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of gastric neoplastic lesions.
The main questions it aims to answer are:
1. Percentage of patients with incomplete closure.
2. Percentage of patients bleeding at closure site within 28 days from procedure.
3. Percentage of patients with infection at closure site within 28 days from procedure.
4. Percentage of patients with leakage within 72 hours from procedure.
5. Serious Adverse Device Effects (SADE) within 28 days from procedure.
6. Overall rates of Adverse Device Effect within 28 days from procedure.
Study includes 6 visits: Screening, Baseline/Surgery, Discharge and 4 weeks, 3 months and 6 months post-surgery. The actual point of enrollment for each subject is considered the day of surgery. Total study duration is up to 6.5 months.
The patient will be admitted to the medical center on the day of the procedure or one day prior for preoperative preparation. Following tissue resection using one of the methods (ESD or EMR), suturing will be performed using the Su2ura® GI system.
Postoperatively, the patient will be transferred to the recovery area and then to the surgical ward for standard monitoring, with an expected one-night postoperative stay and discharge the following day.
Study follow-up visits will take place 4 weeks, 3 and 6 months post surgery.
Detailed Description:
This study will be performed in accordance with the design and specific provisions of this protocol, in accordance with the ethical principles that have their origin in the Declaration of Helsinki, that are consistent with Good Clinical Practice (GCP), Title 21 of the Code of Federal Regulations (21 CFR), part 812 (Investigational Device Exemptions), and the applicable regulatory requirements.
The study will be a prospective, single-center, open study, to evaluate the efficacy and safety of the Su2ura® GI System.
The study will be performed at the Tel Aviv Sourasky Medical Center, Israel. Up to 25 patients will be recruited to the study.
Following resection of the lesion using either endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD), the procedure involves endoscopic insertion of the Su2ura® GI system through the gastroscope working channel, followed by tissue grasping and approximation using sequential deployment of T-Tag Anchors in a predefined suturing pattern. Full-thickness anchors are placed in a controlled manner to achieve safe and effective tissue approximation, after which the suture is secured using the Su2ura® Knot device.
Postoperatively, the patient will be transferred to the recovery area and then to the surgical ward for standard monitoring, with an expected one-night postoperative stay and discharge the following day.
Study:
NCT07315893
Study Brief:
Protocol Section:
NCT07315893