Clinical trial · Interventional
Chitosan Scaffold for Sellar Floor Repair in Endoscopic Endonasal Transsphenoidal Surgery
NCT03280849CI-TRIAL-00037617completedN/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)
A 65 year old female participant , right handed, started with progressive bilateral visual loss in her temporal field, over 10 months, the participant underwent an MRI and it was found a sellar lesion that compressed the optic chiasm, an endoscopic endonasal transsphenoidal surgery was done for the resection of the lesion, using a novel bilaminar chitosan scaffold to assist the closure of the sellar floor. After a follow up of 2 years the participant returned to its normal visual function, without evidence of the sellar lesion on the postoperative MRI, and without complications.
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 |
|---|---|---|---|
| Csf Leakage | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Implant of bilaminar chitosan scaffold | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patient with bilaminar chitosan implant
- description
- A 65 year old woman, right handed, started with progressive bilateral visual loss in her temporal field, over 10 months, she underwent an MRI and it was found a sellar lesion that compressed the optic chiasm, an endoscopic endonasal transsphenoidal surgery was done for the resection of the lesion, using a novel bilaminar chitosan scaffold to assist the closure of the sellar floor.
- interventionNames
- Other: Implant of bilaminar chitosan scaffold
Primary outcomes (10)
- measure
- Brain MRI with and without contrast
- timeFrame
- 1 day preoperative
- description
- Axial-coronal-sagittal MRI in T1,T2 signals-measure of the preoperative tumor size
- measure
- Brain MRI with and without contrast
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * male/female patient candidate for an endoscopic endonasal transphenoidal surgery, who need repair of the sellar floor as part of the surgical procedure. Exclusion Criteria: * Diabetes, heart diseases, immunological diseases, infectious diseases, bone diseases.
References
Publications (24)
- BACKGROUNDGobin AS, Butler CE, Mathur AB. Repair and regeneration of the abdominal wall musculofascial defect using silk fibroin-chitosan blend. Tissue Eng. 2006 Dec;12(12):3383-94. doi: 10.1089/ten.2006.12.3383. PMID 17518675
- BACKGROUNDPaulo NM, de Brito e Silva MS, Moraes AM, Rodrigues AP, de Menezes LB, Miguel MP, de Lima FG, de Morais Faria A, Lima LM. Use of chitosan membrane associated with polypropylene mesh to prevent peritoneal adhesion in rats. J Biomed Mater Res B Appl Biomater. 2009 Oct;91(1):221-7. doi: 10.1002/jbm.b.31393. PMID 19399842
- BACKGROUNDUdpa N, Iyer SR, Rajoria R, Breyer KE, Valentine H, Singh B, McDonough SP, Brown BN, Bonassar LJ, Gao Y. Effects of chitosan coatings on polypropylene mesh for implantation in a rat abdominal wall model. Tissue Eng Part A. 2013 Dec;19(23-24):2713-23. doi: 10.1089/ten.TEA.2012.0739. Epub 2013 Aug 21. PMID 23859182
- BACKGROUNDTchemtchoua VT, Atanasova G, Aqil A, Filee P, Garbacki N, Vanhooteghem O, Deroanne C, Noel A, Jerome C, Nusgens B, Poumay Y, Colige A. Development of a chitosan nanofibrillar scaffold for skin repair and regeneration. Biomacromolecules. 2011 Sep 12;12(9):3194-204. doi: 10.1021/bm200680q. Epub 2011 Aug 1. PMID 21761871
- BACKGROUNDStippler M, Gardner PA, Snyderman CH, Carrau RL, Prevedello DM, Kassam AB. Endoscopic endonasal approach for clival chordomas. Neurosurgery. 2009 Feb;64(2):268-77; discussion 277-8. doi: 10.1227/01.NEU.0000338071.01241.E2. PMID 19190456
- BACKGROUNDGardner PA, Kassam AB, Snyderman CH, Carrau RL, Mintz AH, Grahovac S, Stefko S. Outcomes following endoscopic, expanded endonasal resection of suprasellar craniopharyngiomas: a case series. J Neurosurg. 2008 Jul;109(1):6-16. doi: 10.3171/JNS/2008/109/7/0006. PMID 18590427
- BACKGROUNDGreenfield JP, Anand VK, Kacker A, Seibert MJ, Singh A, Brown SM, Schwartz TH. Endoscopic endonasal transethmoidal transcribriform transfovea ethmoidalis approach to the anterior cranial fossa and skull base. Neurosurgery. 2010 May;66(5):883-92; discussion 892. doi: 10.1227/01.neu.0000368395.82329.c4.