Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
Study NCT ID:
NCT06193551
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2023-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ovitex in Paraesophageal and Large Hiatal Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006551', 'term': 'Hernia, Hiatal'}], 'ancestors': [{'id': 'D006548', 'term': 'Hernia, Diaphragmatic'}, {'id': 'D000082122', 'term': 'Internal Hernia'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Clinical trial with a single arm of patients undergoing elective repair of paraesphageal hiatal hernia repair or large hiatal henia repair with implant of Ovitex-LPR.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2030-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-11', 'studyFirstSubmitDate': '2023-12-11', 'studyFirstSubmitQcDate': '2023-12-20', 'lastUpdatePostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hiatal Hernia Recurrence as assessed by barium swallow demonstrating axial hernia >2 cm', 'timeFrame': '5 years', 'description': 'Assess recurrence rates by objective measures when Ovitex LPR permanent polypropylene polymer reinforcement (Ovitex LPR) is placed during robotic-assisted repair of paraesophageal and large (\\> 5cm) hiatal hernias (henceforth PEH) using recurrence rate measurements defined as \\> 2cm axial hernia by Barium Swallow or endoscopy, if available'}], 'secondaryOutcomes': [{'measure': 'Number of participants with treatment related mesh erosions as assessed by study quality of life questionnaire leading to endoscopy', 'timeFrame': '5 years', 'description': 'Assess the safety of using polypropylene support related to potential erosion as assessed by presence of symptoms using study quality of life questionnaire leading to endoscopy demonstrating mesh erosion'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['paraesophageal hiatal hernia', 'paraesphageal hernia', 'hiatal hernia'], 'conditions': ['Paraesophageal Hernia', 'Large Hiatal Hernia']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the success of hiatal hernia repairs in patients with large (\\>5cm) or paraesophageal hernias when Ovitex LPR mesh used during the repair.', 'detailedDescription': 'This is an investigator initiated, single site, single arm study investigating the recurrence rate of hiatal hernia and safety using Ovitex LPR in patients undergoing hiatal hernia repair.\n\nOvitex LPR mesh is a reinforced tissue matrix, comprised of a fine non-absorbable polymer suture interwoven through layers of absorbable biologic material in a "lockstitch" pattern.The biologic material in OviTex, derived from ovine rumen (sheep stomach), serves as the natural building block and is optimized to reduce foreign body response, enable functional tissue remodeling and promote a more natural hernia repair. The interwoven polymer fibers provide additional reinforcement, along with improved handling and load-sharing capability. The permanent polymer fiber (polypropylene) is a standard surgical suture material that is used in hiatal hernia surgery and comprises less than 5% of the final product.\n\nPreop details, quality of life questionnaires and surgery details will be collected along with post op GERD (gastro esophageal reflux disease) quality of life questionnaires and barium swallow esophagrams to objectively examine recurrence of hiatal hernia at 1, 3, and 5 years post op. Data will be carefully collected and reviewed for discrepancies and verified with source prior to analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-85 year old with PEH and appropriate surgical indication for repair\n\nExclusion Criteria:\n\n* Under 22 years of age.\n* In need of an emergency procedure.\n* Currently being treated with another investigational drug or device.\n* Have had prior gastric or esophageal surgery.\n* Have had any previous intervention for GERD.\n* Are suspected or confirmed to have esophageal or gastric cancer.\n* Have a Body Mass Index (BMI) greater than 45.\n* Cannot understand trial requirements or are unable to comply with follow-up schedule.\n* Are pregnant, nursing, or plan to become pregnant.\n* Have a mental health disorder that would interfere with your ability to follow study instructions.\n* Have suspected or known allergies to Ovitex\n* Have an illness that may cause you to be unable to meet the protocol requirements or is associated with shortened life expectancy.'}, 'identificationModule': {'nctId': 'NCT06193551', 'acronym': 'OviPHeR', 'briefTitle': 'Ovitex in Paraesophageal and Large Hiatal Hernia Repair', 'organization': {'class': 'OTHER', 'fullName': 'Foregut Research Foundation'}, 'officialTitle': 'Ovitex in Paraesophageal and Large Hiatal Hernia Repair. (OviPHeR)', 'orgStudyIdInfo': {'id': 'TelaBio'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients undergoing a paraesophageal or large (>5 cm) hiatal hernia repair', 'description': 'This is a single arm, open label, nonrandomized study evaluating 100 subjects diagnosed with a paraesophageal or large hiatal hernia planning to undergo surgical repair with the study investigators.', 'interventionNames': ['Device: Ovitex LPR']}], 'interventions': [{'name': 'Ovitex LPR', 'type': 'DEVICE', 'description': 'Robotic assisted laparoscopic repair of hiatal hernia using permanent sutures with Ovitex mesh as reinforcement.', 'armGroupLabels': ['Patients undergoing a paraesophageal or large (>5 cm) hiatal hernia repair']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80124', 'city': 'Lone Tree', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kate Freeman, MSN', 'role': 'CONTACT', 'email': 'kate@iersurgery.com', 'phone': '303-788-7700'}, {'name': 'Rachel Heidrick, BSN', 'role': 'CONTACT', 'email': 'rachel@iersurgery.com', 'phone': '303-788-7700', 'phoneExt': '241'}, {'name': 'Reginald Bell, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Philip Woodworth, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Institute of Esophageal and Reflux Surgery', 'geoPoint': {'lat': 39.55171, 'lon': -104.8863}}], 'centralContacts': [{'name': 'Kate Freeman, MSN', 'role': 'CONTACT', 'email': 'kate@iersurgery.com', 'phone': '3037887700'}], 'overallOfficials': [{'name': 'Kate Freeman, MSN', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Foregut Research Foundation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Foregut Research Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}