Clinical trial · Interventional
Comparison of Progel Sealant to Standard of Care (SOC) for Patients Undergoing Decortication
A Randomized Phase III Trial to Compare the Progel Sealant to Standard of Care (SOC) for Patients Undergoing Decortication for Mesothelioma or Other Pathologies
NCT02511600CI-TRIAL-00020201withdrawnPhase 3ClinicalTrials.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 goal of this clinical research study is to compare Progel® (a type of surgical sealant that is made from human blood products) to the standard of care (talcum powder) to learn if one method is better than the other for preventing air leaks in patients having a pleurectomy decortication.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Diseases | — | UNRESOLVED | — |
| Mesothelioma | Malignant Mesothelioma | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pain Questionnaire | Behavioral | — | UNRESOLVED |
| Progel Sealant | Other | — | UNRESOLVED |
| Talcum Powder | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Progel Sealant
- description
- After pleurectomy decortication, Progel® sealant added to the surface of the lung prior to closure of the chest. Participants complete pain scale 3 times each day while in the hospital.
- interventionNames
- Other: Progel Sealant
- Behavioral: Pain Questionnaire
- type
- ACTIVE_COMPARATOR
- label
- Standard of Care
- description
- After pleurectomy decortication, talcum powder added to the surface of the lung prior to closure of the chest. Participants complete pain scale 3 times each day while in the hospital.
- interventionNames
- Other: Talcum Powder
- Behavioral: Pain Questionnaire
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. All patients with mesothelioma or other pathologies undergoing a pleurectomy decortication at MD Anderson Cancer Center 2. Adequate preoperative renal function documented by serum creatinine of \< 1.5 mg/dl or calculated creatinine clearance \> 50 ml/min Exclusion Criteria: 1. Patients unable to consent for the procedure 2. Patients with a history of allergy to human proteins 3. Patients who may have insufficient renal capacity for clearance of Progel® polyethylene glycol load
References
Publications (0)
Data not yet available
No reference posted for this study.