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Gastroparesis clinical trials

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NCT ID: NCT04844190 Terminated - Gastroparesis Clinical Trials

Use of EndoFLIP and Manometry Prior to G-POEM

Start date: September 15, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to assess physiologic response of therapy in patients with refractory gastroparesis undergoing Gastric per-oral endoscopic myotomy (G-POEM) using endoscopic functional lumen imaging probe (EndoFLIP) and antroduodenal manometry (ADM). Refractory gastroparesis will be defined as having delayed gastric emptying at four hours (>10% retention of stomach contents) on gastric scintigraphy and persistent symptoms despite treatment with dietary modification or prokinetic medications. We hypothesize that EndoFLIP and high resolution ADM will provide an individualized pyloric functional profile in gastroparesis patients that can more accurately predict clinical response to G-POEM.

NCT ID: NCT04635306 Terminated - Gastroparesis Clinical Trials

13C-Spirulina Nitrogen Content GEBT Study

Start date: October 21, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether there is a difference in the human in vivo response to 13C-Spirulina meals manufactured using 13C-Spirulina containing different levels of protein (as measured by %nitrogen).

NCT ID: NCT04349891 Terminated - Gastroparesis Clinical Trials

Transcutaneous Electroacupuncture for Gastrointestinal Motility Disorders

TEA
Start date: October 1, 2020
Phase: N/A
Study type: Interventional

Gastrointestinal (GI) dysmotility is common in GI motility disorders, such as functional dyspepsia (FD) gastroparesis and chronic constipation. The symptoms of GI dysmotility include abdominal discomfort or pain, early satiety, nausea, vomiting, abdominal distension, bloating, anorexia and reduced bowel movement. . Medical treatment for GI motility disorders is very limited in the US. Acupuncture has frequently been used for treatment of GI ailments in Eastern countries. The most commonly used acupuncture points (acupoints) for focused treatment of GI symptoms are the Neiguan (PC6) and the Zusanli (ST36) points. Electroacupuncture (EA) at PC6 and ST36 has been reported to accelerate gastrointestinal motility in both animals and human. Recently, the investigators have studied the feasibility of transcutaneous electroacupuncture (TEA): electrical stimulation is applied to acupoints via surface electrodes without needles, similar to the commercial available transcutaneous electrical nerve stimulation (TENS) but applied to acupoints. The investigators hypothesize that TEA as a new treatment option, improves GI symptoms in patients with FD, gastroparesis or constipation, improves GI motility and therefore improves quality of life of the patients. The success of this project will lead to a noninvasive and convenient therapy for treating GI motility disorders. The proposed TEA method is expected to improve gastric and colonic functions and thus improve quality of life. In addition, the proposed TEA method and device are self-administrative after training during the first office visit. It provides a long-term treatment option for both FD, gastroparesis and chronic constipation.

NCT ID: NCT04208698 Terminated - Clinical trials for Diabetic Gastroparesis

A Scintigraphy Study in Adults With Diabetic Gastroparesis

Start date: February 17, 2020
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled scintigraphy study to investigate the effect of oral CIN-102 on gastric emptying and antral contractility in adults with diabetic gastroparesis.

NCT ID: NCT04121325 Terminated - Abdominal Pain Clinical Trials

Gastric Electrical Stimulation for Abdominal Pain in Gastroparesis

Start date: December 18, 2019
Phase:
Study type: Observational

To conduct a pilot study to evaluate the effects of new GES programming settings on abdominal pain in patients with gastroparesis and existing GES devices, whose abdominal pain has so far been refractory to drugs and/or devices.

NCT ID: NCT03987672 Terminated - Gastroparesis Clinical Trials

Study to Intervene With Nutrition for Gastroparesis

SING
Start date: August 1, 2019
Phase: N/A
Study type: Interventional

The study is a self-controlled study in which we will assess the nutritional effects of the Kate Farm Peptide 1.5 nutritional Formula in patients with gastroparesis, relative to their pre-enrollment nutritional diet regimen.

NCT ID: NCT03786380 Terminated - Gastroparesis Clinical Trials

Diabetic Gastroparesis Study 05

Start date: December 20, 2018
Phase: Phase 3
Study type: Interventional

This open-label study is to assess the safety of continued treatment with relamorelin for participants who previously completed the RLM-MD-03 [NCT03420781] or RLM-MD-04 [NCT03383146] study and to provide treatment for these participants until relamorelin becomes commercially available or the Sponsor terminates development.

NCT ID: NCT03757455 Terminated - Pancreatic Cancer Clinical Trials

ERAS Protocol in Pancreaticoduodenectomy and Total Pancreatectomy

Start date: September 1, 2020
Phase: N/A
Study type: Interventional

In the study, the enhanced recovery after surgery (ERAS) program is applied to total pancreatectomy (TP) and low-risk pancreaticoduodenectomy (PD) patients identified by a small number of acinar cells in the cut edge of the pancreas. The research setting is randomized and controlled. All patients arriving at the Tampere University Hospital (TAUH) for PD or TP surgery are recruited into the study. Recruited patients are randomized to the ERAS protocol and to the standard protocol recovery program. The ERAS program differs from the normal care protocol preoperatively, intraoperatively and postoperatively as explained in the following section. In the ERAS protocol, both on the previous day of the surgery and on the following days, the patient is discussed with the patient about the benefits of the protocol used and the recovery program objectives. The purpose is to motivate and encourage the patient. On the day of surgery, the patient's intake of food and fluids is allowed to be closer to the surgery and the patient is also given a carbohydrate drink two hours before surgery. The nasogastric tube set at the beginning of surgery is removed at the end of the surgery and peripancreatic or perihepatic drains are not routinely placed. After surgery, drinking is allowed after four hours and the patient is encouraged to move as actively as possible in the bed. On the first and second postoperative day, the patient is allowed to enjoy normal food and drink according to his or her ability, and pancreatic capsules are given in the course of food. Additionally, the analgesic to be administered through the epidural cannula is dosed as far as possible to allow mobilization of the patient. The discussion on the benefits and recovery targets of the ERAS protocol are continued. On the third postoperative day, the epidural infusion is discontinued and the pain medication is moved to opioid-based pain management. This is continued until specific criteria for passing to the follow-up care are met. Typical complications (pancreatic fistula, delayed gastric emptying, postpancreatectomy hemorrhage) are registered during hospitalization and their severity ratings according to ISGPS, ISPGF and Clavien-Dindo classifications are also determined. Other variables registered are the number of intensive care days, situations requiring new surgeries, 30 and 90 day mortality, the completion time of the criteria for passing to follow up care, and the total length of hospitalization. In addition, the need for readmissions is registered. The implementation of the ERAS protocol is followed by a separate tracking template, in which the nurses record the progress of the goals specified in the protocol on a daily basis. The results of the study are analyzed with the intention-to-treat principle.

NCT ID: NCT03426345 Terminated - Diabetes Mellitus Clinical Trials

Study to Evaluate the Safety and Efficacy of Relamorelin in Participants With Diabetic Gastroparesis Study 02

Start date: February 16, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and efficacy of relamorelin compared to placebo in participants with diabetic gastroparesis. Participants will report daily severity scores of their diabetic gastroparesis symptoms.

NCT ID: NCT03420781 Terminated - Diabetes Mellitus Clinical Trials

A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03

Start date: January 24, 2018
Phase: Phase 3
Study type: Interventional

A 46-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG). At the end of the 40-week Treatment Period, participants will either continue on relamorelin or placebo for 6 additional weeks.