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Clinical Study for Energy Based Devices in Open Gastrectomy for Gastric Cancer

NCT01971775 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2013-10-29

No results posted yet for this study

Summary

Surgery is the first standard treatment for stomach cancer, but it still has negative factors such as bleeding, leakage, closure, surgery part infection and cardiovascular and lung complication by general anesthesia.

electric cautery is used extensively in surgery room due to the utility of simultaneous severance and hemostasis. In some case, the electric current from vitality electrode may unexpectedly stimulate or damage nearby muscles and nerves. Ultrasonically activated shears (UAS) is a device to transform the protein of organ for organ incision or hemostasis. General advantages possibly include shortened operating time, decrease of operative blood loss, and relatively less damages to the normal organ. UAS is commonly used in the operation room, which is now considered as a secure and useful medical device for for tissue dissection and coagulation. Also, it is expected to lower the risk of surgery by reducing operating time and blood loss.

However, clinical evidence is not sufficient for this device until now. Therefore, in this study,

1. Evaluate the utility, efficacy, and safety of energy based device, in the case of open gastrectomy
2. Would like to compare the following two kinds of energy based devices. A. For conventional monopolar electrosurgery group : dissection and sealing will be conducted by conventional monopolar electrocautery device B. For UAS group : dissection and sealing will be conducted by UAS

Conditions

Interventions

DEVICE

Ultrasonically activated Shears

Dissection and lymphovascular sealing with Ultrasonically Activated Shears

DEVICE

Conventional Monopolar Electrocautery

Dissection and lymphovascular sealing with Conventional Monopolar Electrocautery

Sponsors & Collaborators

  • Johnson & Johnson Medical Companies

    collaborator INDUSTRY

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Han-Kwang Yang, M.D., Ph.D. · Seoul National University Hospital, Seoul, Korea, Republic of.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2013-05-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

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 NCT01971775 on ClinicalTrials.gov