Clinical trial · Interventional
Efficacy of Pelvic Autonomic Nerve Monitoring System (PAMS I) in Female Patients With Pelvic Tumors
Exploratory Study for Evaluating the Efficacy of Pelvic Autonomic Nerve Monitoring System (PAMS I) in Female Patients With Pelvic Tumors (FUSION Trial V)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Although nerve-sparing surgery has been introduced for female patients with the pelvic tumors, its success rate depends on operators. To achieve consistency of surgical procedure, It is necessary to adopt pelvic autonomic nerve monitoring technique. The Aims of this study is 1. Development of pelvic autonomic nerve monitoring system (PAMS I) by using urodynamic system. 2. Evaluation of autonomic nerve sparing by intraoperative monitoring with PAMS I 3. Evaluating the efficacy of PAMS I by intraoperative neurophysiological monitoring (IOM)
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Uterine Cancer | Malignant Uterine Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PAMS I | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PAMS I
- description
- During operation, autonomic nerve monitoring will be performed by PAMS I which is composed of two urodynamic systems.
- interventionNames
- Device: PAMS I
Primary outcomes (1)
- measure
- Evaluating efficacy of PAMS I by comparison with IOM
- timeFrame
- Intraoperative
- description
- Comparision pressure change on PAMS I with nerve conduction on IOM i) PAMS I (+) \& IOM (+): nerve-sparing ii) PAMS I (-) \& IOM (-): nerve damage iii) PAMS I (+) \& IOM (-) or PAMS I (-) \& IOM (+): intermediate
Secondary outcomes (4)
- measure
- Evaluation of Quality of life.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female, Age ≥ 18 years * Patients with pelvic malignant tumor who need surgery. * Gynecologic cancer; cervical cancer, uterine cancer, ovarian cancer * Colorectal cancer * Pelvic sarcoma and metastatic pelvic malignant tumor * Patients who signed an approved informed consent. Exclusion Criteria: * Female, Age \< 18 years * Patients with pelvic malignant tumor, but surgery is not indicated. * Patients who refused to sign informed consent
References
Publications (0)
Data not yet available