Manageability and Safety Assessment of Sepraspray in Abdominal Surgery.

NCT ID: NCT00813397

Last Updated: 2015-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-07-31

Brief Summary

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This study will examine the performance of SeprasSpray in patients undergoing abdominal surgery (laparoscopic).

Detailed Description

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Conditions

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Adhesion Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Sepraspray

Receive Sepraspray

Group Type EXPERIMENTAL

Sepraspray

Intervention Type DEVICE

Max. 10g of Sepraspray

Control

No Treatment, No Placebo

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sepraspray

Max. 10g of Sepraspray

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients 18 years old and over that require laparoscopic abdominal surgery

Exclusion Criteria

* Patients who are pregnant or have an ongoing infectious complications from a previous surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Genzyme, a Sanofi Company

Locations

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CHU Amiens Nord

Amiens, , France

Site Status

Hopital Avicenne

Bobingy, , France

Site Status

Hopital Beaujon

Clichy, , France

Site Status

Centre Hospitalier Simone Veil

Eaubonne, , France

Site Status

Hopital Nord

Marseille, , France

Site Status

CHR Nantes-Hopital Hotel Dieu

Nantes, , France

Site Status

CHU Hopital de le'Archet

Nice, , France

Site Status

Institut Mutualiste Montsouris

Paris, , France

Site Status

CHU Bordeaux-Hopital du Haut Leveque

Pessac, , France

Site Status

CHU Lyon Sud

Pierre-Bénite, , France

Site Status

Centre Hospitalier Intercommunal de Poissy Saint-German

Poissy, , France

Site Status

CHU Charles Nicolle

Rouen, , France

Site Status

CHU Bordeaux Saint Andre

Talence, , France

Site Status

Hopital Purpan

Toulouse, , France

Site Status

CHU Hopital Trousseau

Tours, , France

Site Status

Countries

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France

References

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Berdah SV, Mariette C, Denet C, Panis Y, Laurent C, Cotte E, Huten N, Le Peillet Feuillet E, Duron JJ. A multicentre, randomised, controlled trial to assess the safety, ease of use, and reliability of hyaluronic acid/carboxymethylcellulose powder adhesion barrier versus no barrier in colorectal laparoscopic surgery. Trials. 2014 Oct 27;15:413. doi: 10.1186/1745-6215-15-413.

Reference Type DERIVED
PMID: 25348087 (View on PubMed)

Other Identifiers

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SSPRAY00608

Identifier Type: -

Identifier Source: org_study_id

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