Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2026-01-04 @ 8:58 AM
Study NCT ID:
NCT02639195
Status:
UNKNOWN
Last Update Posted:
2017-02-01
First Post:
2015-12-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Small Bowel Obstruction (SBO) on Quality of Life (QOL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007415', 'term': 'Intestinal Obstruction'}], 'ancestors': [{'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-30', 'studyFirstSubmitDate': '2015-12-21', 'studyFirstSubmitQcDate': '2015-12-21', 'lastUpdatePostDateStruct': {'date': '2017-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': '90 days', 'description': 'Questionnaire based study for QOL changes over 90 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Small Bowel Obstruction', 'Quality of Life', 'Bowel Obstruction']}, 'descriptionModule': {'briefSummary': 'This study has two segments the first is a chart and outcome assessment of patients treated at Clear Passage (CP) with a history of small bowel obstruction (SBO). These patients have completed multiple questionnaires as a standard of care for outcome monitoring in the clinic setting, no new data will be collected. The second segment is a prospective observational, online questionnaire based study of subjects with a history of SBO not treated at CP. Data on the impact of quality of life (QOL) over time of subjects not treated at CP will be assessed using the same questionnaire used as standard of care in the clinic twice, 90 days apart. This will be accomplished using the NIH Assessment Center, with subjects able to complete the questionnaires with ease via the internet. As this segment is observational, there is minimal risk to these subjects. The data obtained from the untreated subjects will allow for reporting of overall impact on QOL in this population, data that is not available, as well as provide a control group for assessment of improvement for interventions for SBO.', 'detailedDescription': 'This study has two segments the first is a chart and outcome assessment of patients treated at Clear Passage (CP) with a history of small bowel obstruction (SBO). These patients have completed multiple questionnaires as a standard of care for outcome monitoring in the clinic setting, no new data will be collected. The second segment is a prospective observational, online questionnaire based study of subjects with a history of SBO not treated at CP. Data on the impact of quality of life (QOL) over time of subjects not treated at CP will be assessed using the same questionnaire used as standard of care in the clinic twice, 90 days apart. This will be accomplished using the NIH Assessment Center, with subjects able to complete the questionnaires with ease via the Assessment Center. As this segment is observational, there is minimal risk to these subjects. The data obtained from the untreated subjects will allow for reporting of overall impact on QOL in this population, data that is not available, as well as provide a control group for assessment of improvement for interventions for SBO.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Population with a history of a bowel obstruction in the last 2 years.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 90 years old\n* Previous diagnosis of partial or total bowel obstruction in the last 2 years.\n* Able to complete the questionnaire online via Assessment Center.\n\nExclusion Criteria:\n\n* Currently pregnant\n* Cancer within the last 10 years\n* Chemotherapy or radiation treatments within the last 10 years\n* Prior treatment at Clear Passage'}, 'identificationModule': {'nctId': 'NCT02639195', 'briefTitle': 'The Impact of Small Bowel Obstruction (SBO) on Quality of Life (QOL)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Clear Passage Therapies, Inc'}, 'officialTitle': 'The Impact of Small Bowel Obstruction (SBO) on Quality of Life (QOL); the Efficacy of a Manual Physical Therapy to Improve QOL in Subjects With a History of SBO', 'orgStudyIdInfo': {'id': 'SBO-C2015-005'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treatment, retrospective', 'description': 'Retrospective analysis on patients treated with manual physical therapy in quality of life outcomes as measured by pre and post treatment questionnaires. Chart review.', 'interventionNames': ['Other: Treatment']}, {'label': 'Untreated control', 'description': 'Prospective data collection via questionnaire of subjects with a history of small bowel obstruction in an observational manner. No treatment is performed.'}], 'interventions': [{'name': 'Treatment', 'type': 'OTHER', 'otherNames': ['Manual Therapy'], 'description': 'Retrospective chart review of patients treated with manual therapy.', 'armGroupLabels': ['Treatment, retrospective']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32606', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Clear Passage Physical Therapy', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Amanda Rice, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Clear Passage Therapies'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clear Passage Therapies, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'CEO', 'investigatorFullName': 'Lawrence Wurn', 'investigatorAffiliation': 'Clear Passage Therapies, Inc'}}}}