Clinical trial · Interventional
Fat Grafting for Vaginal Stenosis in Gynaelogical Cancer
Using Fat Tissue GRafting to Treat Symptoms of VAginal Stenosis in Women With Gynaecological Cancer - IDEAL Stage 2a Surgical Study
NCT06015360CI-TRIAL-00070216GRASSunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The GRASS study looks at performing a technique called "Fat Tissue Grafting" to assess whether it can reduce the side effects of vaginal stenosis effects and improve the sexual function of participants who wish to preserve penetrative sexual function
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fat Graft | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fat Grafting
- description
- The fat grafting procedure will be conducted as per local standard RM protocol. All procedures will be conducted by the study Principal Investigator (PI) who is well practiced in performing this procedure in Head \& Neck and breast cancer patients and also in scar revision patients.
- interventionNames
- Procedure: Fat Graft
Primary outcomes (7)
- measure
- Number of patients able to have vaginal penetration without pain (yes / no)
- timeFrame
- 11 months
- description
- Ability to have vaginal penetration , this is descriptive and will be provided as a yes / no answer by the patient at their follow up visit
- measure
- Number of patients with an increase in the volume of the rectovaginal septum on pelvic MRI imaging
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Patients with cervical cancer * At least 2 years since finishing pelvic radiotherapy for gynaecological cancer * Treated at RM * Persistent symptoms of vaginal stenosis despite prior use of vaginal dilators/ oestrogen replacement / lubricants/moisturisers * Desiring vaginal intercourse Exclusion Criteria: * Evidence of recurrent disease documented on Magnetic Resonance Imaging (MRI) * Patients unwilling / unable to provide written informed consent for the study
References
Publications (0)
Data not yet available
No reference posted for this study.