Pelvic MRINERVWATCHNCT03320343
Pilot Study of Measurement Agreement Between Morphological and Diffusion Tensor Imaging MRI for Pelvic Nerve Cartography
An observational study of Pelvic MRI, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The investigators hypothesize that diffusion tensor imaging (DTI) will produce a similar map of autonomic pelvic innervation to that obtained using 3D morphological MRI sequences Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pelvic MRI
- What is being tested?
- MRI
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 22 Feb 2019to 19 Jul 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted to the Medical Imaging Department of the CHU Nîmes for an MRI examination of the pelvic region for any reason
Who may be able to join
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- The patient it at least 18 years old
- The patient has been admitted for an MRI examination of the pelvic region, for any reason
Who cannot join
- The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- The patient is pregnant or breast feeding
- There is a contra-indication for MRI (pacemaker, claustrophobic patient)
- The patient has had previous pelvic surgery
Trial locations and contacts
1 site in 1 country.
About this study
The investigators hypothesize that diffusion tensor imaging (DTI) will produce a similar map of autonomic pelvic innervation to that obtained using 3D morphological MRI sequences
- Conditions
- Pelvic MRI
- Being tested
- MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
3D morphological MRI and diffusion tensor imaging
| Study group | Role | What they receive |
|---|---|---|
| Patients recruited for pelvic imaging examination | Not described Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between DTI imaging measures versus 3D morphological MRI measures for point of penetration of the pelvic splanchnic nerves in the lower hypogastric plexus
Lin's concordance correlation coefficient and Bland-Altman Plot
Measured: Day 0
Agreement between DTI imaging measures versus 3D morphological MRI measures for point of penetration of the pelvic hypogastric nerves in the lower hypogastric plexus
Lin's concordance correlation coefficient and Bland-Altman Plot
Measured: Day 0
Agreement between DTI imaging measures versus 3D morphological MRI measures for origin of the cavernous nerves
Lin's concordance correlation coefficient and Bland-Altman Plot
Measured: Day 0
Secondary outcomes (4)
Acquisition time
min
Measured: Day 0
Time necessary for sequence reconstruction
min
Measured: Day 0
Inter-operator agreement
Kappa coefficient of measurements between two operators
Measured: Day 0
Intra-operator agreement
Kappa coefficient of measurements from same operator 6 months apart
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start22 Feb 2019
- Primary completion19 Jul 2019
- Study completion19 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic MRIStudies of the same condition, open and under way.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320343
- Sponsor's protocol ID
- NIMAO/2017-01/MB-01
- Acronym
- NERVWATCH
- Status last verified
- Jun 2026
- First submitted
- 17 Oct 2017
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Measurement Agreement Between Morphological and Diffusion Tensor Imaging MRI for Pelvic Nerve Cartography
- ClinicalTrials.gov ID
- NCT03320343
- Acronym / sponsor ID
- NERVWATCH / NIMAO/2017-01/MB-01
- Conditions
- Pelvic MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 22 Feb 2019 (actual)
- Primary completion
- 19 Jul 2019 (actual)
- Study completion
- 19 Jul 2019 (actual)
- First posted
- 25 Oct 2017 (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.
The investigators hypothesize that diffusion tensor imaging (DTI) will produce a similar map of autonomic pelvic innervation to that obtained using 3D morphological MRI sequences
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients recruited for pelvic imaging examination | – | Other: MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to the Medical Imaging Department of the CHU Nîmes for an MRI examination of the pelvic region for any reason
Key inclusion criteria (4 listed)
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- The patient it at least 18 years old
- The patient has been admitted for an MRI examination of the pelvic region, for any reason
Key exclusion criteria (7 listed)
- The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- The patient is pregnant or breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI3D morphological MRI and diffusion tensor imaging | Other | Patients recruited for pelvic imaging examination |
Primary outcome
Agreement between DTI imaging measures versus 3D morphological MRI measures for point of penetration of the pelvic splanchnic nerves in the lower hypogastric plexus
Time frame: Day 0
Lin's concordance correlation coefficient and Bland-Altman Plot
Agreement between DTI imaging measures versus 3D morphological MRI measures for point of penetration of the pelvic hypogastric nerves in the lower hypogastric plexus
Time frame: Day 0
Lin's concordance correlation coefficient and Bland-Altman Plot
Agreement between DTI imaging measures versus 3D morphological MRI measures for origin of the cavernous nerves
Time frame: Day 0
Lin's concordance correlation coefficient and Bland-Altman Plot
4 secondary outcomes
Acquisition time
Time frame: Day 0
Time necessary for sequence reconstruction
Time frame: Day 0
Inter-operator agreement
Time frame: Day 0
Intra-operator agreement
Time frame: Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic MRI, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between DTI imaging measures versus 3D morphological MRI measures for point of penetration of the pelvic splanchnic nerves in the lower hypogastric plexus (time frame: Day 0). The study lists 3 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 16 Jun 2026.