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Fistula clinical trials

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NCT ID: NCT02751333 Withdrawn - Esophageal Fistula Clinical Trials

Esophageal Stent Migration With Endoscopic Suture Fixation Compared to Standard Deployment

Start date: March 2016
Phase: Phase 2
Study type: Interventional

Esophageal stents are commonly used for benign esophageal pathology, especially strictures or esophageal mucosal defects such as leaks, fistulae, or perforations. The major limiting factor to stent placement is the high migration rate of the stent. Investigators are trying to prospectively evaluate the efficacy of endostitch in preventing stent migration in benign esophageal disease in comparison with standard, fully covered self-expanding metal stents (FCSEMS) placement without fixation.

NCT ID: NCT02678936 Withdrawn - Rectal Fistula Clinical Trials

Anal Fistula Repair With Platelet-rich Plasma

Aurora
Start date: November 2015
Phase: Phase 4
Study type: Interventional

Anal fistula is a very common disease with a high impact on life quality. The only commonly accepted treatment option is surgery. A wide range of operations and techniques have been developed all suffering from a relatively high recurrence rate. The investigators propose the combination of the mucosal advancement flap with application of platelet-rich plasma (PRP) in the fistulectomy site. This study aims to test the hypothesis that by applying PRP the healing rate of complicated anal fistulas can be improved in comparison to a control group where the operation is performed without addition of PRP.

NCT ID: NCT02519192 Withdrawn - Fistulae Clinical Trials

The Role of VAC Therapy Devices in Promoting Closure of Enterocutaneous Fistulae

ECF
Start date: January 2016
Phase: N/A
Study type: Interventional

This study hopes to determine if a negative pressure dressing is superior to a traditional dressing for speeding fistula closure after laparotomy. This study has a broad variety of implications. Patient safety is a paramount concern: Investigators hope to identify a superior method of wound management which minimizes risk for skin breakdown, sepsis, and morbidity. In addition, patient satisfaction would be improved with a method for faster wound healing. Finally,implications exist in the realm of a cost-benefit analysis, for example, although the VAC method is more costly, it may save money if it speeds healing and prevents the need for reoperation. Alternatively, if the VAC method is not shown to be beneficial, physicians can avoid using a more costly device with no proven benefit.

NCT ID: NCT02305992 Withdrawn - Clinical trials for Arteriovenous Fistula

Regional Anesthesia for Arteriovenous Fistula

Start date: December 2015
Phase: N/A
Study type: Interventional

Once kidney function goes below 10 to 15 percent of normal, dialysis treatments or a kidney transplant are necessary to sustain life. One type of dialysis is hemodialysis which cleans blood by removing it from the body and passing it through a dialyzer, or artificial kidney. To maximize the amount of blood cleansed during hemodialysis treatments, there should be continuous high volumes of blood flow. A fistula used for hemodialysis is a direct connection of an artery to a vein. Once an arteriovenous fistula (AVF) is created it is a natural part of the body. This is the preferred type of access because once the fistula properly matures and gets bigger and stronger; it provides an access with good blood flow that can last for decades. After the fistula is surgically created, it can take weeks to months before the fistula matures and is ready to be used for hemodialysis. There have been surgical factors identified; one of them being the anesthetic used which may cause a fistula not to survive. This study will look at comparing 3 anesthetic techniques: axillary block (AB) versus stellate ganglion (SGB) block+local anesthetic versus local anesthetic (LA).

NCT ID: NCT02183194 Withdrawn - Clinical trials for Dysfunctional AV Graft

Paclitaxel Coated PTA Balloons for Treatment of Dysfunctional AV Fistulae and Grafts

ACCESS
Start date: July 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the Lutonix® 035 Drug Coated Balloon PTA Catheter (CE mark) for use as intended in the treatment of subjects with clinically significant hemodialysis vascular access stenosis or occlusion.

NCT ID: NCT02085486 Withdrawn - Dialysis Clinical Trials

Ultrasound Assisted Puncture of AV Fistulas in Chronic Hemodialysis Patients

Start date: August 2017
Phase: N/A
Study type: Interventional

The puncture of the vascular access in hemodialysis patients remains challenging even in the hands of experienced dialysis nurses. Unsuccessful punctures are associated with resource wastage, traumatism of the AV shunts, shortening of the effective dialysis time and poor patient satisfaction. The use of ultrasound by emergency department nurses and technicians without prior ultrasound experience in patients with difficult intravenous access showed in several studies to be very efficient. The investigators expect to achieve similar results in cannulation of AV shunts by the dialysis nurse staff after a short learning program. To show this, the investigators aim to conduct a trail where standard cannulation technique (inspection, palpation) will be compared with the ultrasound-assisted method in terms of efficacy, safety and patient satisfaction.

NCT ID: NCT02040454 Withdrawn - Clinical trials for Arteriovenous Access Fistula Stenosis

Paclitaxel for the Treatment of Distal Radial Artery Arteriovenous Access Fistula Stenosis (PaciFIST-2)

PaciFIST-2
Start date: March 2014
Phase: Phase 2
Study type: Interventional

The objective of this study is to evaluate the safety and effectiveness of the use of intravascular paclitaxel, in addition to standard therapy, for the treatment of arteriovenous dialysis access fistula stenosis. A fistulogram will be performed in standard fashion. The diagnostic component will include evaluation of the inflow artery, arterial anastomosis and full length of the fistula vein or graft, plus venous return up to the heart. The location, vessel size, lesion diameter and percent stenosis for each lesion will be recorded. Enrollment and randomization will occur at this point. All patients will then receive standard therapy for their stenosis. This will include intravenous heparin administered in a standard dose of 70 units/kg. Lesions that respond poorly to angioplasty (>30% residual stenosis after angioplasty treatment with 2 inflations) will be stented. Stent selection will be based on clinical setting. Initial stent treatment will utilize an uncovered nitinol stent. Treatment of in-stent restenosis will include initial balloon angioplasty, and use of a covered stent (Viabahn, GORE, or Fluency, Bard). Documentation of location and type of treatment for each lesion treated will be recorded. Once standard treatment is completed, the operating surgeon will be informed of the results of randomization: treatment (paclitaxel) or control. For subjects assigned to treatment, the whole fistula vein outflow segment of the fistula will be treated with paclitaxel. The full length of the radial artery from 1 cm of its origin to fistula anatomosis will be treated with paclitaxel. In addition the anastomosis and first 4 cm of the fistula vein will be treated. Paclitaxel solution treatment of each lesion encountered will be attempted until the 20 mg Paclitaxel dose limit is met. The volume administered will depend on the diameter and length of the vessels treated. Maximization of the length of vessel and lesions treated will be undertaken when there are more lesions than can be accommodated by the 12 mg, 10 ml dose available. A 5 F sheath, 20 cm in length, will be used to administer the paclitaxel. This will be advanced from its distal position in the radial artery over the guidewire so that the tip of the sheath is in the proximal radial artery. Prior to removal of the sheath, a final angiographic study of all areas treated is performed to document patency and lesion appearance. Any additional lesions identified with this study are then treated appropriately following standard technique. For the control group, instead of paclitaxel administration, a sham treatment period of 10 minutes is allowed to elapse followed by the performance of the final completion angiogram. Any additional lesions identified with this study are then treated appropriately following standard technique. All patients will follow the same follow up evaluation schedule

NCT ID: NCT01913249 Withdrawn - Anorectal Fistula Clinical Trials

Effect of Short Term Versus Long Term Treatment With Seton Prior to LIFT Surgery for Complex Anal Fistula

Start date: September 2013
Phase: N/A
Study type: Interventional

The aim of this study is to compare short term (3 week) with long term (6 months) treatment with seton prior to LIFT surgery. The main end-points are recurrence rates and complication rates after surgery.

NCT ID: NCT01872312 Withdrawn - Clinical trials for Management of BPF (Bronchopleural Fistulae)

Spiration IBV® Valve System and Spiration Airway Sizing Kit

Start date: March 25, 2012
Phase: N/A
Study type: Interventional

This procedure allows patients to use the Humanitarian Use Device, IBV® Valve System.

NCT ID: NCT01635543 Withdrawn - Crohn's Disease Clinical Trials

Investigation of Sexual Function in Crohn's Disease Patients With Perianal Fistulas

Start date: October 2011
Phase: N/A
Study type: Observational

Objective: The aim of this study is to investigate whether Crohn's Disease patients with peri-anal fistulas will suffer from sexual dysfunction in an attempt to help us identify Crohn's Disease patients that would benefit from sexual health interventions. Hypothesis: Crohn's patients with active perianal fistulas will have decreased sexual drive, performance, and satisfaction than those with Crohn's Disease in remission.