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A multicenter, prospective, randomized, parallel controlled clinical trial to validate the safety and effectiveness of biodegradable magnesium clips in ligating vessels and/or tissues during surgery

A multicenter, prospective, randomized, parallel controlled clinical trial to validate the safety and effectiveness of biodegradable magnesium clips in ligating vessels and/or tissues during surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026698
Enrollment
Unknown
Registered
2019-10-19
Start date
2019-10-21
Completion date
Unknown
Last updated
2020-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

When ligating vessels and tissues during surgery

Interventions

Trial Test:Biodegradable magnesium clips
Experimental group:Biodegradable Magnesium Clips
Control Group:ABSOLOK clips

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. 18 < Age <= 75, both female and male. 2. When needs ligating vessles or tissues during surgery. 3. Trial subjects or his/her guardian can understand the aim of the trial, has good compliance to follow-up, and sign informed consents voluntarily.

Exclusion criteria

Exclusion criteria: 1. Tissues needing ligation has lesion, such as tumor, lithiasis or stone incarceration. 2. Has blood calcium disorder, or blood magnesium disorder, or blood phosphorous disorder, of clinical significance. 3. Coagulation disorder. 4. Has history of mental disease, has long term of intemperance or has drug abuse. 5. Has important organs' disorder or other severe illness that is unsuitable for surgery. 6. Prepare to pregnant, or has been already pregnant, or in suckling period. 7. Has already participated other medicine or medical devices clinical trials in nearly 3 months. 8. Not suitable for participanting the present trial determined by researchers.

Design outcomes

Primary

MeasureTime frame
ligation success rate;

Secondary

MeasureTime frame
assessment of operation performance;safety assessment;assessment of surgery duration;

Countries

China

Contacts

Public ContactTao Suo

Zhongshan Hospital, Fudan University

suo.tao@zs-hospital.sh.cn+86 13681971201

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026