NCT04327050

Brief Summary

This study uses magnetic anchored guidance system to treat early gastric cancer by endoscopic mucosal dissection to test the advantages of magnetically anchored guidance system for surgical field exposure during endoscopic mucosal dissection.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable gastric-cancer

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable gastric-cancer

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 30, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

March 30, 2020

Status Verified

March 1, 2020

Enrollment Period

12 months

First QC Date

March 26, 2020

Last Update Submit

March 27, 2020

Conditions

Gastric Cancer

Keywords

magnetic anchored guidanceearly gastric cancerendoscopic submucosal dissection

Outcome Measures

Primary Outcomes (1)

  • success rate

    The rate of the complete resection of gastric lesion by magnetic anchored guided endoscopic submucosal dissection

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • complications

    measured at the time of the end of each ESD; up to 1 hour

Study Arms (1)

Magnetic-ESD

EXPERIMENTAL

Patients in MAG arm will be treated using magnetic anchored guided endoscopic submucosal dissection.

Procedure: Magnetic anchored guided endoscopic submucosal dissection

Interventions

Magnetic anchored guided endoscopic submucosal dissectionPROCEDURE

Using magnetic anchoring technology, the magnetic pulling unit is anchored to the abdominal wall, and micro surgical tweezers are used. The tumor tissue is pulled indirectly, so that the mucosa is lifted up, which is beneficial to the peeling of the submucosa.

Magnetic-ESD

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients are diagnosed as of gastric cancer by a preliminary endoscopy or biopsy sampling

You may not qualify if:

  • Patients with a cardiac pacemaker or severe cardiac and/or pulmonary diseases
  • Patients without informed consent
  • Patients with other malignant tumors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Yi Lv, MD

    First Affiliated Hospital Xi'an Jiaotong University

    PRINCIPAL INVESTIGATOR

  • Shuixiang He, MD

    First Affiliated Hospital Xi'an Jiaotong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaogang Zhang, MD

CONTACT

0086-028-8532390047608867@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
No masking required
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2020

First Posted

March 30, 2020

Study Start

May 1, 2020

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

March 30, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share