Accuracy of Coplanar Template Assistance for Pelvic and Groin Areas Biopsy

Sponsor

Peking University Third Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05419141

Collaborator

(none)

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In recent years, template guidance has been applied and developed in the field of puncture related operations, such as template-assisted radioactive seed implantation. With the guidance of template, needle pathway of seed implantation, biopsy and fiducial marker implantation can be precisely planned

, which is conducive to accurate proceeding. Templates can be divided into coplanar templates and non-coplanar templates. The digital coplanar template coordinate puncture system has been developed in China and has been applied in clinical practice. In our previous studies, coplanar template assisted CT-guided radioactive seed implantation has good clinical feasibility for percutaneous biopsy of small pulmonary nodules. However, the accuracy of coplanar template assistance for abdominal tumor puncture are lacking in prospective studies. The study aims to prospectively observe the accuracy and safety of coplanar template assisted CT-guided Pelvic and Groin Areas biopsy.

Condition or Disease	Intervention/Treatment	Phase
Pelvic and Groin Areas Biopsy

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Prospective Study on Accuracy and Safety of Coplanar Template Assisted CT-guided Pelvic and Groin Areas Biopsy

Actual Study Start Date :

Jun 20, 2022

Anticipated Primary Completion Date :

Jun 20, 2024

Anticipated Study Completion Date :

Jun 20, 2024

Outcome Measures

Primary Outcome Measures

Accuracy of Depth [during the operation]
Depth (millimeter) difference between actual puncture and planned puncture pathway
Accuracy of Angle [during the operation]
Angle (degree) difference between actual puncture and planned puncture pathway

Secondary Outcome Measures

Success rate of needle puncture [during the operation]
Success rate of needle puncture
Complication rate [perioperative the operation]
such as pneumoperitoneum, subcutaneous emphysema, hemorrhage, infection, etc.
operating duration [during the operation]
operating duration from the starting to the ending
Number of CT scans [during the operation]
Number of CT scans

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

Ages 18 to 90
Single or multiple Pelvic and Groin Areas mass (solid, partially solid)
Without taking drugs affecting coagulation and/or platelet aggregation are used; If used, the drug has been discontinued for a sufficient period of time (e.g. 1 week)

Page 3 of 4 [DRAFT] -

KPS>60 points, no serious or uncontrolled underlying diseases, clinical evaluation patients can tolerate puncture
Planned biopsy with applicable puncture path
With informed consent.

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University Third Hospital	Beijing	Beijing	China
2	Bin Qiu, M.D.	Beijing		China

Sponsors and Collaborators

Peking University Third Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Qiu Bin, Principal Investigator, Peking University Third Hospital

ClinicalTrials.gov Identifier:

NCT05419141

Other Study ID Numbers:

ChiECRCT20220127

First Posted:

Jun 15, 2022

Last Update Posted:

Jul 20, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Qiu Bin, Principal Investigator, Peking University Third Hospital

Study Results

No Results Posted as of Jul 20, 2022