GI Neuromuscular Pathology Prospective Registry
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02165059 |
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Recruitment Status :
Recruiting
First Posted : June 17, 2014
Last Update Posted : February 14, 2022
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Sponsor:
Indiana University
Information provided by (Responsible Party):
John M. Wo, Indiana University
| Tracking Information | |||||||||
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| First Submitted Date | June 12, 2014 | ||||||||
| First Posted Date | June 17, 2014 | ||||||||
| Last Update Posted Date | February 14, 2022 | ||||||||
| Study Start Date | December 2013 | ||||||||
| Estimated Primary Completion Date | December 2025 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Clinical data at 4 time periods for study patents will be measured [ Time Frame: 2 years ] Follow up clinical data will be obtained before, 6 months, 1.5 years, and 2 years after the full thickness biopsy.
Follow up clinical data PAGI-SYM Overall Treatment Effect by Patient Overall Treatment Effect by Physician
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | GI Neuromuscular Pathology Prospective Registry | ||||||||
| Official Title | Indiana University GI Neuromuscular Pathology Prospective Registry | ||||||||
| Brief Summary | In this research study, biopsy samples will be collected to provide more insight into the underlying cause of the motility disorders, help direct further investigation into the cause of the underlying condition, provide future prognosis and predict response to gastric electrical stimulation (GES). | ||||||||
| Detailed Description | Biopsies will be collected from patients that have been diagnosed with gastroparesis (having nausea, retching, bloating and fullness of stomach) and are undergoing surgery for the GES implantation. These patients will serve as our study group population. Biopsy samples of those who do not have gastroparesis but are undergoing surgery on the digestive system will be collected after the patients consent to be on the trial. These patients will serve as our control group population. Detailed medical history will be collected and the study group patients will be asked to complete two questionnaire to assess the severity of the symptoms. They will be followed in the clinic at 6, 12, 18 and 24 months post implantation. | ||||||||
| Study Type | Observational [Patient Registry] | ||||||||
| Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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| Target Follow-Up Duration | 2 Years | ||||||||
| Biospecimen | Retention: Samples Without DNA Description: Full thickness biopsies of Gastric body and proximal jejunum obtained.
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients who have been diagnosed with gastropareiss and are undergoing surgery for full thickness biopsy GES implantation willl serve as our study group, Patients who are undergoing surgery on the digestive system but do not have gastroparesis, will serve as our control group. | ||||||||
| Condition | Gastroparesis | ||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
300 | ||||||||
| Original Estimated Enrollment |
200 | ||||||||
| Estimated Study Completion Date | December 2025 | ||||||||
| Estimated Primary Completion Date | December 2025 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria | Inclusion Criteria Study Group: Patients who are undergoing surgical full-thickness biopsy of the stomach and/or proximal jejunum for the clinical evaluation of GI neuromuscular disorder. Inclusion Criteria Control Group: Patients undergoing esophagectomy, sleeve gastrectomy for obesity, or Roux-en Y gastric bypass Patients undergoing Whipple surgery Patients undergoing transplant surgery Patients who are organ donors and undergoing surgery Exclusion Criteria Study Group: Contraindication for surgical full-thickness biopsy for any reason. Significant comorbidity due to severe cardiovascular, renal, pulmonary, or liver disease. Significant coagulopathy Non-ambulatory patients: bed-ridden, nursing home resident. Pregnant Unable to give own informed consent Prisoners Exclusion Criteria Control Group: Prior diagnosis of gastroparesis Prior diagnosis of chronic intestinal pseudo-obstruction Unable to give own informed consent if not an organ donor |
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| Sex/Gender |
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| Ages | 6 Months to 90 Years (Child, Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts |
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| Listed Location Countries | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT02165059 | ||||||||
| Other Study ID Numbers | GI Neuromuscular Pathology | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product | Not Provided | ||||||||
| IPD Sharing Statement | Not Provided | ||||||||
| Current Responsible Party | John M. Wo, Indiana University | ||||||||
| Original Responsible Party | Indiana University | ||||||||
| Current Study Sponsor | Indiana University | ||||||||
| Original Study Sponsor | Same as current | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | Indiana University | ||||||||
| Verification Date | February 2022 | ||||||||