Pelvic and Groin Areas BiopsyNCT05419141
Accuracy of Coplanar Template Assistance for Pelvic and Groin Areas Biopsy
An observational study of Pelvic and Groin Areas Biopsy, run by Peking University Third Hospital at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pelvic and Groin Areas Biopsy
- How many people
- 30 participants
- Where
- 2 sitesChina
- Study dates
- 20 Jun 2022to 20 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
Study population: 1. Poor organ function (e.g. lung function FEV1<40% and/or DLCO<50%) 2. The lesion close to blood vessels and intestine, or there is portal vein hypertension and superior vena cava compression, etc., which are expected to have high risks of puncture bleeding and intestinal injury 3. Poor compliance and unable to complete coordination 4. Paticipant who is considered inappropriate or unwilling to participate in this clinical trial for other reasons.
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality
Bin Qiu, M.D., 01082265968, 542122203@qq.com
- Not yet recruiting
Bin Qiu, M.D.
Beijing
Bin Qiu, 01082265968, 542122203@qq.com
About this study
Official title: A Prospective Study on Accuracy and Safety of Coplanar Template Assisted CT-guided Pelvic and Groin Areas Biopsy
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.
- Conditions
- Pelvic and Groin Areas Biopsy
- Keywords
- Pelvic, Groin, Biopsy, Coplanar template.
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Depth
Depth (millimeter) difference between actual puncture and planned puncture pathway
Measured: during the operation
Accuracy of Angle
Angle (degree) difference between actual puncture and planned puncture pathway
Measured: during the operation
Secondary outcomes (4)
Success rate of needle puncture
Success rate of needle puncture
Measured: during the operation
Complication rate
such as pneumoperitoneum, subcutaneous emphysema, hemorrhage, infection, etc.
Measured: perioperative the operation
operating duration
operating duration from the starting to the ending
Measured: during the operation
Number of CT scans
Number of CT scans
Measured: during the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start20 Jun 2022
- Primary completion20 Jun 2024 (estimated)
- Study completion20 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic and Groin Areas BiopsyStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiu Bin, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05419141
- Sponsor's protocol ID
- ChiECRCT20220127
- Status last verified
- Jul 2022
- First submitted
- 10 Jun 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on Accuracy and Safety of Coplanar Template Assisted CT-guided Pelvic and Groin Areas Biopsy
- ClinicalTrials.gov ID
- NCT05419141
- Acronym / sponsor ID
- ChiECRCT20220127
- Conditions
- Pelvic and Groin Areas Biopsy
- Keywords
- Pelvic, Groin, Biopsy, Coplanar template.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 20 Jun 2024 (estimated)
- Study completion
- 20 Jun 2024 (estimated)
- First posted
- 15 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 1. Poor organ function (e.g. lung function FEV1<40% and/or DLCO<50%) 2. The lesion close to blood vessels and intestine, or there is portal vein hypertension and superior vena cava compression, etc., which are expected to have high risks of puncture bleeding and intestinal injury 3. Poor compliance and unable to complete coordination 4. Paticipant who is considered inappropriate or unwilling to participate in this clinical trial for other reasons.
Key inclusion criteria (7 listed)
- 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)
- KPS>60 points, no serious or uncontrolled underlying diseases, clinical evaluation patients can tolerate puncture
- Planned biopsy with applicable puncture path
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of Depth
Time frame: during the operation
Depth (millimeter) difference between actual puncture and planned puncture pathway
Accuracy of Angle
Time frame: during the operation
Angle (degree) difference between actual puncture and planned puncture pathway
4 secondary outcomes
Success rate of needle puncture
Time frame: during the operation
Complication rate
Time frame: perioperative the operation
operating duration
Time frame: during the operation
Number of CT scans
Time frame: during the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic and Groin Areas Biopsy, run by Peking University Third Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Depth (time frame: during the operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.