[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07098715":3,"trial-entities:NCT07098715":86,"trial-summary:NCT07098715":90},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":36,"secondary_outcomes":41,"sex":42,"minimum_age":43,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":44,"std_ages":63,"locations":66,"central_contacts":76,"overall_officials":77,"references":81,"see_also_links":82},"NCT07098715","24-007753","A Study Of Cryptoglandular Fistula-in-ano And Associated Non-healing Draining Wounds With Kerecis SurgiClose","Closure Of Cryptoglandular Fistula-in-ano And Associated Non-healing Draining Wounds With Kerecis SurgiClose","ENROLLING_BY_INVITATION","2027-09","2025-09","2025-09-19","2025-09-11","Mayo Clinic","OTHER",false,"The purpose of this study is to determine feasibility of Kerecis intact fish skin for healing of fistula-in-ano and associated non-healing draining wounds.",null,[19,20],"Fistula-in-ano","Draining Wound",[],"INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},20,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DEVICE","Kerecis fish skin","To assess shot-term outcomes (rates of healing) using Kerecis intact fish skin to heal cryptoglandular fistula-in-ano and associated chronic non-healing draining wounds.",[35],"Intact Kerecis Fish Skin",[37],{"measure":38,"description":39,"timeFrame":40},"Fistula healing","Assess healing of the fistula. This will be determined based on physical examination. A healed fistula will be a patient who 6 months after surgery no longer has drainage or evidence of infection. The internal opening should be closed on physical exam. The internal opening should feel closed on digital rectal exam. This will be assessed in each patient to determine the overall rate of healing.","From device implant until 6 months after",[],"ALL","18 Years",{"inclusion":45,"exclusion":49,"raw_text":62},[46,47,48],"Adults age ≥18 years old","Cryptoglandular fistula-in-ano (primary or recurrent)","The ability to give appropriate consent",[50,51,52,53,54,55,56,57,58,59,60,61],"Age \\\u003C18 years old","Pregnant (as determined by urine test)","Any known allergies or sensitivities to fish material","Prisoners","Inflammatory bowel disease","Fistula-in-ano associated with:","Anal cancer","Rectal cancer","Extramammary Paget's disease","Hidradenitis suppurativa","Anal condyloma","Active infection \u002F abscess","Inclusion Criteria:\n\n* Adults age ≥18 years old\n* Cryptoglandular fistula-in-ano (primary or recurrent)\n* The ability to give appropriate consent\n\nExclusion Criteria:\n\n* Age \\\u003C18 years old\n* Pregnant (as determined by urine test)\n* Any known allergies or sensitivities to fish material\n* Prisoners\n* Inflammatory bowel disease\n* Fistula-in-ano associated with:\n\n  * Anal cancer\n  * Rectal cancer\n  * Extramammary Paget's disease\n  * Hidradenitis suppurativa\n  * Anal condyloma\n  * Active infection \u002F abscess",[64,65],"ADULT","OLDER_ADULT",[67],{"facility":68,"city":69,"state":70,"zip":71,"country":72,"geoPoint":73},"Mayo Clinic in Rochester","Rochester","Minnesota","55905","United States",{"lat":74,"lon":75},44.02163,-92.4699,[],[78],{"name":79,"affiliation":13,"role":80},"Nicholas P. McKenna, MD","PRINCIPAL_INVESTIGATOR",[],[83],{"label":84,"url":85},"Mayo Clinic Clinical Trials","https:\u002F\u002Fwww.mayo.edu\u002Fresearch\u002Fclinical-trials",{"nct_id":4,"conditions":87,"biomarkers":89},[88],"Cryptoglandular Fistula-in-ano",[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]