NCT07707024 Intraoperative Neuromonitoring of Sacral Reflexes to Predict Post Operative Function in Patients Undergoing Sacrectomy for Pelvic Bone Malignancy or Patients Undergoing Spinal Procedures Without Sacral Root Involvement
| NCT ID | NCT07707024 |
| Status | Recruiting |
| Phase | — |
| Sponsor | City of Hope Medical Center |
| Condition | Bone Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2027-01-10 |
| Primary Completion | 2029-06-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2027-01-10 with a primary completion date of 2029-06-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This clinical trial tests how well monitoring the sacral reflexes during surgery (intraoperatively) works to predict the post operative function for patients undergoing removal of the lowest part of the spine (sacrectomy) for pelvic bone cancers or patients undergoing spinal procedures. These surgical procedures can lead to damage to sacral root nerves which can result in impairment to the lower extremities, bowel, bladder, and sexual function. Intraoperative monitoring of sacral reflexes can provide objective, real-time information about pelvic nerve function during surgery. This can aid surgical decision-making and help surgeons better prepare patients to understand the changes that may have occurred to their function as a result of surgery. Intraoperative neuromonitoring may work well to predict postoperative function in patients undergoing sacrectomy for pelvic bone malignancy or patients undergoing spinal procedures.
Eligibility Criteria
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative. * Assent, when appropriate, will be obtained per institutional guidelines * Age: ≥ 18 years * Ability to complete study questionnaires * Willingness to comply with all study procedures, including postoperative patient-reported outcome (PRO) assessments * Undergoing surgery at City of Hope involving either: * Complete or partial sacrectomy for primary or metastatic bone tumors, or * Thoracolumbar intervention in which the sacral roots are not exposed or manipulated (reference cohort) Exclusion Criteria: * Prior sacrectomy or prior surgery resulting in complete sacral nerve transection * For thoracolumbar cohort patients, prior diagnosis or patient report of bowel or bladder dysfunction * Cognitive or psychiatric conditions preventing reliable completion of PRO instruments
Contact & Investigator
Alana M Munger
PRINCIPAL INVESTIGATOR
City of Hope Medical Center
Frequently Asked Questions
Who can join the NCT07707024 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bone Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07707024 currently recruiting?
Yes, NCT07707024 is actively recruiting participants. Visit ClinicalTrials.gov or contact City of Hope Medical Center to inquire about joining.
Where is the NCT07707024 trial being conducted?
This trial is being conducted at Duarte, United States.
Who is sponsoring the NCT07707024 clinical trial?
NCT07707024 is sponsored by City of Hope Medical Center. The principal investigator is Alana M Munger at City of Hope Medical Center. The trial plans to enroll 50 participants.