Disposable endoscopic linear stapler cartridges for cutting, resection, and creating anastomoses
Post-Market Clinical Follow-Up Study Plan for Cartridges of Disposable Endoscopic Linear Cutting Staplers
This project will test disposable endoscopic linear stapler cartridges and powered staplers in adults having open or minimally invasive general, gynecologic, urologic, or thoracic surgery to see if they are safe and work well.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Suzhou Care-Real Medical Technology Co., Ltd. Academic / other |
| Locations | 1 site (Ningbo, Zhejiang) |
| Trial ID | NCT07028554 on ClinicalTrials.gov |
What this trial studies
This is a post‑market, observational program collecting clinical data on Ningbo Verykind disposable endoscopic linear cutting staplers and cartridges used for transection, resection, and anastomosis across multiple surgical specialties. Investigators will gather intraoperative details and follow‑up outcomes to monitor device performance, staple behavior over the follow‑up period, and any side effects or contraindications. The program enrolls adults (≥18 years) undergoing open or endoscopic general, gynecologic, urologic, or thoracic procedures in participating centers and excludes cases with contraindicated tissue use or concurrent similar devices. Data are being collected from sites in regions including Italy, Brazil, and Chile to confirm continued safety and benefit‑risk acceptability in real‑world practice.
Who should consider this trial
Good fit: Adults aged 18 or older undergoing open or endoscopic general, gynecologic, urologic, or thoracic surgery where these staplers and cartridges are used are eligible.
Not a fit: Patients with contraindications such as use on large arteries, ischemic or necrotic tissue, tissue thickness outside the device range, those treated with similar concurrent stapling devices, or with incomplete operative records may not benefit.
Why it matters
Potential benefit: If successful, the program could confirm device safety and performance and help reduce device‑related complications during surgical cutting, resection, and anastomosis.
How similar studies have performed: Similar disposable stapling systems have long been used across many surgical procedures with generally favorable safety records, though device‑specific post‑market data remain necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age≥18 years old, gender unlimited; 2. The surgery type shall be open or endoscopic surgery; 3. The departments of surgical procedures: general, gynecologic, urologic and thoracic surgical procedures; 4. Investigational devices listed in this PMCF plan must be used during surgical procedures. Exclusion Criteria: 1. Patients with surgical contraindications to the product, e.g. use the instruments on large arteries, on ischemic or necrotic tissue, use the device on tissues with a compression thickness out of the device range; 2. Concomitant with similar devices (staplers/reloads/cartridges, etc.) for resection, transection and anastomosis of surgical organ or tissues; 3. The operation record is incomplete, and the information related to the main indicators cannot be extracted.
Where this trial is running
Ningbo, Zhejiang
- Cartridges of Disposable Endoscopic Linear Cutting Staplers — Ningbo, Zhejiang, Chile (Recruiting)
Study contacts
- Study coordinator: Ke Zhou
- Email: ke.zhou@care-real.com
- Phone: +86 18118447767
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.