NCT04184973Recrutement en cours
Efficacy and Safety of the CG-100 Intraluminal Bypass Device
Résumé
A randomized trial to assess the safety and efficacy of CG-100 for reducing stoma creation rate in subjects undergoing mesorectal excision.
Critères d'inclusion
1. The patient is willing to comply with protocol-specified follow-up evaluations 2. Patient 22-65 years of age at screening, or patient 66-70 years of age at screening with up to one cardiovascular, metabolic or pulmonary comorbidity for which medication is prescribed. 3. Patient is diagnosed with colorectal cancer 4. Patient is scheduled for elective either open, laparoscopic or robotic with mesorectal excision (either abdominal or transanal approach) which will require the creation of an anastomosis, maximally 10 cm from the anal verge 5. Patients who are scheduled to receive a protective stoma under routine clinical practice during their primary planned operation. 6. Patient is scheduled to undergo mechanical bowel preparation 7. The patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the appropriate Medical Ethics Committee (EC) or Institutional Review Board (IRB).
Critères d'exclusion
1. Patient has local or systemic infection at the time of intervention (e.g., peritonitis) 2. Major surgical or interventional procedures within 45 days prior to this study or planned surgical or interventional procedures within 6 months of entry into this study (not including, placement of port for chemotherapy or ureter stent insertion). 3. Patients with ASA classification \> 3 4. Albumin \< 30 g/liter 5. Patient has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, ischemic bowel, carcinomatosis or extensively spread inflammatory bowel disease 6. Patients has a diagnosis of coagulopathy, thrombocytopenia, immune suppression 7. BMI ≥ 40 8. Patient is going through another surgical procedure (other than ileostomy, adhesiolysis) during the surgery. 9. The patient is currently participating in another investigational drug or device study unless pre-approved by the sponsor. 10. Patient has been taking regular systemic/ steroid medication in the last 6 months. 11. Patients is taking antimetabolites or antiplatelet agents. 12. Patient has preexisting sphincter problems 13. Patient has evidence of extensive local disease in the pelvis or has undergone a prior pelvic anastomosis. 14. Patients with massive diverticulosis at the sigmoid/descending colon (viewed on preoperative CT) 15. Any condition or abnormality which in the opinion of the investigator may jeopardize the patient's safe participation or the quality of the data 16. Pregnant or nursing female patients. Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to surgical procedure per site standard test.
Contacts
Les coordonnées de l'équipe de l'essai s'affichent sur demande.
Voir la fiche officielle de l'essai- Statut
- Recrutement en cours
- Phase
- Sans phase (N/A)
- Type d'étude
- Interventionnelle
- Pays
- Suisse, Allemagne, Italie, États-Unis, Israël
- Promoteur
- Colospan Ltd.(Industrie)
- N° de protocole
- CLD-075
- Pathologies
- Rectal Cancer, Rectal Tumor, Rectal/Anal
- Interventions
- Dispositif, Procédure
Traitements évalués
- CG-100 intraluminal bypass device
- Stoma
Lieux · 7
- Lausanne, SuisseCHUVRecrute dans ce centre
- Hamburg, AllemagneAsklepiosRecrute dans ce centre
- Milan, ItalieHumanitas Research HospitalRecrute dans ce centre
- San Diego, États-UnisKaiser Permanente San Diego medical CenterRecrute dans ce centre
- Aurora, États-UnisColorado University Anschutz Medical CampusRecrute dans ce centre
- Detroit, États-UnisHenry Ford Health SystemRecrute dans ce centre
- Beersheba, IsraëlSoroka University Medical CenterRecrute dans ce centre
Au total, dans le monde, 7 des 10 centres listés au registre recrutent ; les 3 autres ne recrutent pas actuellement.
Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 6 juillet 2026).
Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.
Voir aussi
Autres versions
Ces résultats sont indicatifs et ne remplacent pas un avis médical — à discuter avec votre médecin.